Breast Cancer Archives

 

A New Standard of Care for HER2-Positive Metastatic Breast Cancer?

This podcast was originally published by Dr. Rashmi Murthy on December 11, 2019 on breastcancer.org here.


Dr. Rashmi Murthy, assistant professor of breast medical oncology at the University of Texas MD Anderson Cancer Center in Houston, discusses the results of the HER2CLIMB study that she presented at the 2019 San Antonio Breast Cancer Symposium showing that the experimental medicine tucatinib offers benefits to people diagnosed with HER2-positive metastatic breast cancer and may be a new standard of care.

Listen to the episode to hear Dr. Murthy explain:

  • A summary of the study results
  • Why this study included people with brain metastases
  • The side effects of tucatinib
  • Why she thinks the results are practice changing

What Is A Breast Bioposy?

A breast biopsy is a test that removes tissue or sometimes fluid from the suspicious area. The removed cells are examined under a microscope and further tested to check for the presence of breast cancer. A biopsy is the only diagnostic procedure that can definitely determine if the suspicious area is cancerous.

The good news is that 80% of women who have a breast biopsy do not have breast cancer.

There are three types of biopsies:

  • Fine-needle aspiration
  • Core-needle biopsy
  • Surgical biopsy

The latter two are the most commonly used on the breast.

There are several factors that help a doctor decide which type of biopsy to recommend. These include the appearance, size, and location of the suspicious area on the breast. Before discussing biopsy results, let’s first distinguish between the three types of biopsies.

What is fine-needle aspiration?

In most cases, a fine needle aspiration is chosen when the lump is likely to be filled with fluid. If the lump is easily accessible or if the doctor suspects that it may be a fluid-filled cystic lump, the doctor may choose to conduct a fine-needle aspiration (FNA). During this procedure, the lump should collapse once the fluid inside has been drawn and discarded. Sometimes, an ultrasound is used to help your doctor guide the needle to the exact site, whereby sound waves create a picture of the inside of the breast.

If the lump persists, the surgeon or radiologist, a doctor who specializes in medical imaging such as x-rays and mammograms, will perform a fine needle aspiration biopsy (FNABx), a similar procedure using the needle to obtain cells from the lump for examination.


What is a core-needle biopsy?

Core needle biopsy is the procedure to remove a small amount of suspicious tissue from the breast with a larger “core” (meaning “hollow”) needle. It is usually performed while the patient is under local anesthesia, meaning the breast is numbed. During the procedure, the doctor may insert a very small marker inside the breast to mark the location of the biopsy. If surgery is later required, the marker makes it easier for the surgeon to locate the abnormal area.

The radiologist or surgeon performing the core-needle biopsy may use specialized imaging equipment to guide the needle to the desired site. As with fine-needle aspiration, this may involve ultrasound.

During an ultrasound-guided core needle biopsy, the patient lies down while the doctor holds the ultrasound against the breast to direct the needle. On the other hand, during a stereotactic-guided core-needle biopsy, the doctor uses x-ray equipment and a computer to guide the needle. Typically, the patient is positioned lying on the stomach on a special table that has an opening for the breast, and the breast is compressed, similar to a mammogram.

Occasionally, no imaging equipment is used, but this is typically only in cases where the lump can be felt through the skin. This type of procedure is called a freehand core-needle biopsy.

There are fewer side effects associated with a core-needle biopsy than with surgical biopsy.

What should I expect from a surgical biopsy?

(Also known as “wide local excision,” “wide local surgical biopsy,” “open biopsy,” or “lumpectomy”)

As with a core-needle biopsy, a surgical biopsy is done while the patient is under local anesthesia. Typically, this test is performed in a hospital setting where an IV and medications are administered to make the patient drowsy.

The surgeon makes a one- to two-inch cut on the breast and then removes all or part of the abnormal lump and often a small amount of normal-looking tissue, known as the “margin.” If the lump cannot be easily felt but can be seen on a mammogram or ultrasound, a radiologist may insert a thin wire to mark the suspicious spot prior to the surgeon performing the biopsy. Once again, a marker is usually placed internally at the biopsy site at the conclusion of the procedure.


What Can Be Learned From The Biopsy Results?

Once the biopsy is complete, a specially trained doctor called a pathologist examines the tissue or fluid samples under a microscope, looking for abnormal or cancerous cells. The pathology report, which can take one or two weeks to complete, is sent to the patient’s doctor. It indicates whether the suspicious area is cancerous and provides a full picture of your situation. For the patient, waiting for results can be a real challenge, but being able to make an informed decision regarding your treatment is well worth it. Your doctor will go over the report with you and, if necessary, discuss the treatment options.

If no cancer cells are found, the report will indicate that the cells in the lump are benign, meaning non-cancerous. However, some type of follow-up or treatment may still be needed, as recommended by the healthcare professional.

If cancer cells are found, the report will provide more information to help determine the next steps.

The report for a core-needle biopsy sample will include tumor type and the tumor’s growth rate or grade. If cancer is found, the pathologist will also perform lab tests to look at cells for estrogen or progesterone receptors.

In the case of a surgical biopsy, the results reveal data about the type, grade, and receptor status of the tumor, as well as the distance between the surrounding normal tissue and the excised tumor. The margin, as we mentioned earlier, shows whether the site is clear of cancer cells.

A positive margin means cancer cells are present at the margin of the tumor. In cases of positive margins, the cancer has spread beyond the immediate area.

A negative margin or clear margin indicates there are no tumor cells at the margin. That means the cancer is contained in the area nearest to the tumor.

A close margin means that the space between the cancerous tissue and surrounding normal tissue is less than about 3 millimeters (0.118 inch).

If you have a biopsy resulting in a cancer diagnosis, the pathology report will help you and your doctor talk about the next steps. You will likely be referred to a breast cancer specialist, and you may need more scans, lab tests, or surgery. Your medical team uses the pathology report and the results of the other tests to determine the stage of cancer and to design the best treatment plan for you.


Material on this page courtesy of:


Related reading:

5 Things Newly Diagnosed Breast Cancer Patients Should Know

This was originally published by Cynthia Demarco on April 19, 2019 on MD Anderson Cancer Center here.


If you’ve just received a breast cancer diagnosis, you probably have a lot of questions: What type of breast cancer do I have? How advanced is it? Do I qualify for any clinical trials? Can my doctor provide the treatment I need?

Before you start making treatment plans and scheduling appointments, here are five things to know.

Get an accurate diagnosis before starting treatment

Not all breast cancers are the same, so it’s important to get an accurate diagnosis right from the start. This is particularly true if you have a rare or very aggressive form of the disease, such as inflammatory or triple-negative breast cancer.

That’s because the type of breast cancer, as well as its stage and location, can determine the types of treatment you’ll be offered, as well as those you’re not eligible for.

“We offer precise treatments based on precise diagnoses,” says Lavinia Middleton, M.D. “That’s why I believe everyone should get a second opinion. A second opinion can be a game-changer. About 25% of our patients will see a change in their diagnosis.”

Where you go first for breast cancer treatment matters

All patients who come to MD Anderson will have their diagnoses confirmed by our doctors. This ensures that your cancer is both correctly identified and accurately staged — two crucial steps in determining which treatment plans you’ll be offered.

“Your first shot is your best shot at beating cancer,” says Makesha Miggins, M.D. “So, when patients come to us after they’ve already been elsewhere, their cancer treatment is often more challenging. That’s why I tell people to come to MD Anderson first.”

“If my cancer had been just a little more advanced, it would have been considered stage IV, and my care would have been palliative instead of curative,” adds Jenée Bobbora, an inflammatory breast cancer survivor. “But my doctor insisted that my cancer was at stage IIIc, not IV, so my treatment included chemotherapy, a double mastectomy and radiation. And I’ve shown no evidence of disease since 2003.”

Seek out the experts for your breast cancer diagnosis and treatment

It’s also critical to choose a cancer center with extensive experience in treating your particular type of breast cancer.

MD Anderson sees thousands of breast cancer patients annually, and has entire teams of specialists focused on specific types of breast cancer, such as triple-negative and hereditary cancers.

“Not only can we identify rare types of cancer with confidence, we can also keep women from having invasive diagnostic procedures for conditions that are not cancer,” says Therese Bevers, M.D.

“Breast cancer can have so many different variables,” adds Kelly Hunt, M.D. “And each one influences our treatment recommendations, because each one can significantly impact a patient’s response to different therapies. It’s critical to know these things before leaping in, because often by doing chemotherapy or targeted therapy first, we’re able to shrink the tumor and eradicate cancer in the lymph nodes involved. That means we can do less surgery and still have excellent long-term results.”

Consider clinical trials for your breast cancer treatment

Clinical trial options exist for virtually every type and stage of breast cancer. But some clinical trials for breast cancer are limited to patients who have not yet begun treatment. That’s why it’s important to discuss your options with your physician as early as possible.

Over the past few years, clinical trials at MD Anderson have allowed our breast cancer patients to avoid double mastectomieshave tumors removed painlessly without general anesthesia, and explore more personalized treatment options.

“My trial was unique because I was able to start with traditional chemotherapy and move on to other treatments only if that didn’t work,” says breast cancer survivor Barbara Lewis, of the immunotherapy clinical trial she participated in. “Only seven months after diagnosis, there were no traces of cancer in my body. That’s about the best result you can get.”

Make multidisciplinary care mandatory

No matter what type of breast cancer you have, it’s crucial to seek treatment at a cancer center that offers multidisciplinary care. This approach, which was pioneered here at MD Anderson, brings together all of the specialists you’ll need for your care — such as oncologists, surgeons, radiation oncologists, etc. —  to formulate your treatment plan.

Coordinating patient care as a team ensures that every aspect of an individual’s situation is taken into account from the start. It also makes it easier for your care team to adapt and make changes to your treatment as it evolves.

“It’s all about preserving options,” Hunt says. “I see patients all the time who were treated elsewhere with surgery first, when that might not have been the best approach. Now, they need more surgery or other treatments. And they’re painted into a corner, because they have fewer options. Our comprehensive approach means patients don’t have to go through multiple procedures to get the best results.”

Multidisciplinary care also gives patients easy access to any additional support services they might need, such as social work counselorsdietitians, physical therapists, lymphedema specialists and support groups.

“My gynecologist gave me the name of three Houston oncologists to choose from, but it was up to me to check them out,” adds Helen Vollmer, on the challenging start to her breast cancer journey. But once she got to MD Anderson’s Breast Multi-Team Clinic, “It was all confined to one, incredibly caring place with a team who talked to each other and, more importantly, to me.”

Understanding Patient-Centered Care via Alliance for Patient Access

The Alliance for Patient Access created a video to help you understand patient-centered care.

Triage Cancer’s Quick Guide to Health Insurance: Employer-Sponsored & Individual Plans

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Triage Cancer’s Quick Guide to Health Insurance: Medicare

2019-Health-Insurance-Medicare-Quick-Guide-Final

Understanding Clinical Trials: A Jargon Buster Guide

When it comes to cancer treatment you or a loved one may be considering participating in a clinical trial as a treatment option.  Clinical trials are designed to evaluate the safety and effectiveness of a treatment. They may involve researchers administering drugs, taking blood or tissue samples, or checking the progress of patients as they take a treatment according to a study’s protocol.

Learning about clinical trials can be a steep learning curve – not least because the process comes with a lot of new terms, acronyms and jargon.  To help you, I’ve put together this list of the most common terms you will find when you are researching clinical trial information. This is not an exhaustive list but it is a helpful starting point. At the end of this article you will see links to find more information.

Adverse Effects (AE)

Also called Adverse Events, or Adverse Drug Reaction, AEs are any harmful event experienced by a person while they are having a drug or any other treatment or intervention. In clinical trials, researchers must always report adverse events, regardless of whether or not the event is suspected to be related to or caused by the drug, treatment or intervention.

Arm

Subsection of people within a study who have a particular intervention.

Bias

Bias is an error that distorts the objectivity of a study. It can arise if a researcher doesn’t adhere to rigorous standards in designing the study, selecting the subjects, administering the treatments, analysing the data, or reporting and interpreting the study results. It can also result from circumstances beyond a researcher’s control, as when there is an uneven distribution of some characteristic between groups as a result of randomization.

Blinding

Blinding is a method of controlling for bias in a study by ensuring that those involved are unable to tell if they are in an intervention or control group so they cannot influence the results. In a single-blind study, patients do not know whether they are receiving the active drug or a placebo. In a double-blind study, neither the patients nor the persons administering the treatments know which patients are receiving the active drug. In a triple-blind study, the patients, clinicians/researchers and the persons evaluating the results do not know which treatment patients had. Whenever blinding is used, there will always be a method in which the treatment can be unblinded in the event that information is required for safety.

Comparator

When a treatment for a specific medical condition already exists, it would be unethical to do a randomized controlled trial that would require some participants to be given an ineffective substitute. In this case, new treatments are tested against the best existing treatment, (i.e. a comparator). The comparator can also be no intervention (for example, best supportive care).

Completed

A trial is considered completed when trial participants are no longer being examined or treated (i.e. no longer in follow-up); the database has been ‘locked’ and records have been archived.

Control

A group of people in a study who do not have the intervention or test being studied. Instead, they may have the standard intervention (sometimes called ‘usual care’) or a dummy intervention (placebo). The results for the control group are compared with those for a group having the intervention being tested. The aim is to check for any differences. The people in the control group should be as similar as possible to those in the intervention group, to make it as easy as possible to detect any effects due to the intervention.

Efficacy

How beneficial a treatment is under ideal conditions (for example, in a laboratory), compared with doing nothing or opting for another type of care. A drug passes efficacy trials if it is effective at the dose tested and against the illness for which it is prescribed.

Eligibility Criteria/ Inclusion and Exclusion Criteria

Eligibility criteria ensures patients enrolling in a clinical trial share similar characteristics (e.g. gender, age, medications, disease type and status) so that the results of the study are more likely due to the treatment received rather than other factors.

Follow-up

Observation over a period of time of participants enrolled in a trial to observe changes in health status.

Informed Consent

A process (by means of a written informed consent form) by which a participant voluntarily agrees to take part in a trial, having been informed of the possible benefits, risks and side effects associated with participating in the study.

Intervention

The treatment (e.g., a drug, surgical procedure, or diagnostic test) being researched. The intervention group consists of the study participants that have been randomly assigned to receive the treatment.

Investigator

A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator (PI).

Multicentre Trial

A clinical trial conducted according to a single protocol but at more than one site, and therefore, carried out by more than one investigator.

Number needed to treat (NNT)

The average number of patients who need to receive the treatment or other intervention for one of them to get the positive outcome in the time specified.

Outcome Measures

The impact that a test, treatment, or other intervention has on a person, group or population.

Phase I, II, III and IV Studies

Once the safety of a new drug has been demonstrated in tests on animals, it goes through a multi-phase testing process to determine its safety and efficacy in treating human patients. If a drug shows success in one phase, the evaluation moves to the next phase

  • Phase 1 tests a drug on a very small number of healthy volunteers to establish overall safety, identify side effects, and determine the dose levels that are safe and tolerable for humans.
  • Phase II trials test a drug on a small number of people who have the condition the drug is designed to treat. These trials are done to establish what dose range is most effective, and to observe any safety concerns that might arise.
  • Phase III trials test a drug on a large number of people who have the condition the drug is designed to treat. Successful completion of Phase III is the point where the drug is considered ready to be marketed.
  • Phase IV trials can investigate uses of the drug for other conditions, on a broader patient base or for longer term use.

Placebo

A fake (or dummy) treatment given to patients in the control group of a clinical trial.  Placebos are indistinguishable from the actual treatment and used so that the subjects in the control group are unable to tell who is receiving the active drug or treatment. Using placebos prevents bias in judging the effects of the medical intervention being tested.

Population

A group of people with a common link, such as the same medical condition or living in the same area or sharing the same characteristics. The population for a clinical trial is all the people the test or treatment is designed to help.

Protocol

A plan or set of steps that defines how something will be done. Before carrying out a research study, for example, the research protocol sets out what question is to be answered and how information will be collected and analysed.

Randomized Controlled Trial (RCT)

A study in which a number of similar people are randomly assigned to 2 (or more) groups to test a specific drug, treatment or other intervention. One group has the intervention being tested; the other (the comparison or control group) has an alternative intervention, a placebo, or no intervention at all. Participants are assigned to different groups without taking any similarities or differences between them into account. For example, it could involve using a computer-generated random sequence. RCTs are considered the most unbiased way of assessing the outcome of an intervention because each individual has the same chance of having the intervention.

Reliability

The ability to get the same or similar result each time a study is repeated with a different population or group.

Sample

People in a study recruited from part of the study’s target population. If they are recruited in an unbiased way, the results from the sample can be generalised to the target population as a whole.

Subjects

In clinical trials, the people selected to take part are called subjects. The term applies to both those participants receiving the treatment being investigated and to those receiving a placebo or alternate treatment.

Trial Site

The location where trial-related activities are conducted.


References

The Canadian Institutes of Health Research (CIHR)

TROG Cancer Research

ICH.org

NICE

Further Resources

American Society of Clinical Oncology’s Cancer.Net trials site

National Cancer Institute (NCI) Clinical Trials lists open and closed cancer clinical trials sponsored or supported by NCI. 

ClinicalTrials.gov database of privately and publicly funded clinical studies

CenterWatch Clinical Trials Listing

Complete Guide To Mindfulness

Suja Johnkutty Hi there ! I’m Suja Johnkutty, MD a conscientious mom and neurologist . My one simple goal is to provide you honest, practical, simple action steps to experience better relaxation in your life. betterrelaxation.com

Overall Health and Mindfulness Improves Treatment Response: An Expert Explains

Overall Health and Mindfulness Improves Treatment Response: An Expert Explains from Patient Empowerment Network on Vimeo.

Dr. Sangmin Lee shares the benefits of meditation and yoga and explains how mindfulness can affect your overall health.

Dr. Sangmin Lee is a hematologist-oncologist specializing in blood disorders and blood cancers at Weill Cornell Medicine and New York Presbyterian Hospital. More about Dr. Lee here.

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Transcript:

Patricia:

How about this one? A positive attitude and mindfulness can improve treatment response.

Dr. Lee:

Absolutely. Absolutely. Treatment for leukemia can be tough. Some of the treatment involves intense chemotherapy. Treatment for leukemia can involve stem cell transplant. And a key important aspect of treatment is being healthy and being optimistic about treatment, because a lot of treatment can have side effects, and side effects can be not as apparent if you are physically more active, and in a good state. So, I think that having a positive outlook is very, very important.

Patricia:

Quality of life issues are difficult for some people. How do you talk with your patients about their quality of life, and staying healthy during their treatment?

Dr. Lee:

So, quality of life is absolutely important. I mean, the whole point of treating leukemia and any other treatment is not only to address the leukemia, but also have good quality of life. So, when discussing treatment options, you always have to balance the quality of life and side effects versus potential benefits. So, that’s always on our mind when discussing potential treatment options, and how it impacts the quality of life. Throughout the treatment process, we always tell our patients that being active, and having a good quality of life, and having good nutrition, is absolutely important, because that’s a key aspect of treatment for leukemia.

Patricia:

What about meditation and yoga for coping with anxiety around cancer diagnosis and treatment? Mindfulness.

Dr. Lee:

Absolutely, absolutely. Those can help. Especially having leukemia, it’s very life-changing, so a typical way that patients are diagnosed with acute leukemia is patients live a normal life, and then they develop, all of a sudden, abnormalities. And they’re diagnosed with acute leukemia, and it can be very sudden. And it can be very difficult. So, that can understandably make patients have anxiety, and other issues.

And I believe that meditation, and yoga, and other exercises can absolutely help cope with this.

Patricia:

And there’s tons of resources for meditation and yoga out there, that are reliable.

Dr. Lee:

Yes. Yeah.

Patricia:

Yeah. Should patients regard yoga and meditation as part of their treatment, as part of their self-care, during this process?

Dr. Lee:

Absolutely, absolutely, if the patients are into meditation and yoga. Meditation is very harmless, and it can absolutely help in terms of guiding their mind through their treatment journey. Yoga is good if you’re physically able to do it. So, one caution is that, if you’re not someone who does yoga normally, then you should start off slow, and not push yourself as aggressively.

Does Cannabis Oil Have a Role in Cancer Treatment?

Does Cannabis Oil Have a Role in Cancer Treatment? from Patient Empowerment Network on Vimeo.

Is it just a trend or could cannabis oil truly have a role in cancer care and treatment? Dr. Sangmin Lee share his perspective.

Dr. Sangmin Lee is a hematologist-oncologist specializing in blood disorders and blood cancers at Weill Cornell Medicine and New York Presbyterian Hospital. More about Dr. Lee here.

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Transcript:

Patricia:

The use of cannabis oil is becoming prevalent. Does this have a role in cancer care and treatment?

Dr. Lee:

Absolutely. So, we use it for a lot of side effect management. So, cannabis can be helpful, in terms of appetite and nausea, for example. So, we often use it in conjunction to manage some of the side effects that patients can have throughout their treatment.

You should consult with your medical team, and of course, I should say that laws differ state by state, so it doesn’t apply to every state. But when it’s available, it can be a valuable addition.

Patricia:

Sure. Discuss that with your physician.

Sugar Feeds Cancer: Fact or Fiction?

Sugar Feeds Cancer: Fact or Fiction? from Patient Empowerment Network on Vimeo.

Does sugar feed cancer? Dr. Sangmin Lee addresses the rumored connection between sugar and cancer.

Dr. Sangmin Lee is a hematologist-oncologist specializing in blood disorders and blood cancers at Weill Cornell Medicine and New York Presbyterian Hospital. More about Dr. Lee here.

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AML Treatment Side Effects: What’s Fact and What’s Fiction?

Transcript:

Patricia:

Okay, a little more fact or fiction, here. This is what we’ve heard from patients who have AML about cures, okay? Sugar feeds cancer, and severely restricting my diet will treat my AML.

Dr. Lee:

That’s not proven so far. There are some laboratory studies, especially with keto diets, showing some promise, maybe. But then it hasn’t been proven in humans, yet. The most important thing about AML treatment is actually nutrition. As patients go through AML treatment, it’s very important to stay healthy, and part of that is nutrition.

So, starvation, in general, is not recommended, because nutrition is so important, in terms of being able to undergo the treatment, as well as treatment visits, and everything. So, we recommend that nutrition is very important.

Are Clinical Trial Participants Monitored More Closely?

Are Clinical Trial Participants Monitored More Closely? from Patient Empowerment Network on Vimeo.

Dr. Sangmin Lee discusses the monitoring of clinical trial participants and the measures taken for patient safety.

Dr. Sangmin Lee is a hematologist-oncologist specializing in blood disorders and blood cancers at Weill Cornell Medicine and New York Presbyterian Hospital. More about Dr. Lee here.

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Transcript:

Patricia:

How about this next one? I am monitored more closely in a clinical trial.

Dr. Lee:

In some cases, it’s true. Clinical trials do have certain monitoring visits, in terms of doctor’s visits, laboratory tests, and physical exams.

The purpose of that is to make sure that it is safe. So, the purpose of monitoring closely, in a lot of cases, is for the patient’s safety. We are testing drugs in a lot of clinical trials, for which the complete safety profile, as well as efficacy profile, is not known. So, the purpose of closer monitoring is to make sure whatever we’re doing is safe, and if there are any unexpected side effects, then it allows us to address the side effects, as well. So, it’s mainly for patients’ safety.

Will Clinical Trials Cost You? The Facts.

Will Clinical Trials Cost You? The Facts. from Patient Empowerment Network on Vimeo.

Dr. Sangmin Lee reviews the financial impact associated with clinical trials, including a discussion of what expenses are covered for participants.

Dr. Sangmin Lee is a hematologist-oncologist specializing in blood disorders and blood cancers at Weill Cornell Medicine and New York Presbyterian Hospital. More about Dr. Lee here.

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Transcript:

Patricia:

All right, how about this one: I may have unexpected costs if I join a clinical trial.

Dr. Lee:

So, typically, that’s actually, usually not true, because how it works is that the clinical trial drugs, and that there may be extra procedures or visits associated with clinical trials.

And what usually happens is that the sponsor of the clinical trial provides the cost of the drug, intervention, and anything extra that are required for the clinical trial. So, in the end, the cost of participating in a clinical trial should not be any more than receiving standard care treatment.

In some rare cases, there may be stipends associated with the clinical trial, especially with travel. So, if you participate in a clinical trial, and you live far away, then you should ask to see if there is any stipends available, especially for travel.

Is It Safe? Breaking Down the Clinical Trial Process

Is It Safe? Breaking Down the Clinical Trial Process from Patient Empowerment Network on Vimeo.

The idea of a clinical trial can be intimidating and confusing for many patients. Dr. Sangmin Lee explains the phases of clinical trials, including the safety protocols in place to protect patients.

Dr. Sangmin Lee is a hematologist-oncologist specializing in blood disorders and blood cancers at Weill Cornell Medicine and New York Presbyterian Hospital. More about Dr. Lee here.

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Transcript:

Patricia:

What is the process for getting medicine to patients during clinical trials?

Dr. Lee:

So, clinical trials are basically what’s needed to prove that drugs work. So, a lot of times, we test drugs in a test tube in AML cell lines, and they show great promise. But just because a drug works in a test tube setting, doesn’t actually mean that it will work in humans, because human bodies are much more complicated. So, we need to test promising drugs in humans to make sure they are safe and effective.

And that’s what the purpose of clinical trials are. Once they demonstrate safety and efficacy, then a drug then gets to be approved, and is available commercially. So, that’s the purpose of clinical trials.

To be involved in clinical trials, what it involves is, basically, you have to meet a sort of criteria, called eligibility, because different clinical trials have different criteria for selection. So, we have to look into that. And then, once you fit an eligibility or selection criteria, then you typically undergo certain diagnostic tests to enroll on a clinical study. And then, you get whatever drug or intervention that is designed to test in that setting.

So, there are numerous steps to actually enroll in a clinical study.

Patricia:

And like you mentioned, there’s a long way between rat studies and human trials. What are the phases of clinical trials?

Dr. Lee:

So, there are three phases for clinical trials, commonly. There’s phase one, and phase two, and phase three. Phase one is the earliest part of the clinical trial process. So, goal of a phase one study is to make sure a drug is safe in a human. So, phase one studies are usually the first time that you are testing the drug in humans, and the main purpose is to demonstrate that it’s safe. So, typically, in a phase one study, typically, you test a drug at a lower dose or dose levels to demonstrate safety. What it means is that you’re enrolling a few patients at a time.

Once a drug is proven to be safe, then you move on to phase two, which is basically testing the drug in more patients. And the purpose of phase two is to get a preliminary assessment of how effective a treatment would be.

So, typically, a phase two study involves many more patients in that setting. And then, if a phase two study shows that a drug is very promising, then the drug may move on to phase three, where, basically, in phrase three, you are comparing one intervention or a drug compared to the standard of care. And, typically, in a phase three setting, a computer decides randomly which intervention you get, whether it’s an intervention or new drug versus standard of care. And standard of care may include either placebo or chemotherapy intervention, that is standard of care. So, it’s not always placebo in phase three.

Examining the Link Between Gestational Diabetes and Breast Cancer

Approximately 12% of all U.S. women will develop invasive breast cancer during the course of their lives. There are a number of common risk factors associated with breast cancer, such as excessive alcohol consumption, obesity, genetic mutations like BRCA1 and BRCA2, and a family history of breast cancer.  In recent years, the link between diabetes, and particularly gestational diabetes, and cancer has been examined more closely to determine whether this group of women are especially at risk. A better understanding of gestational diabetes and its long-term effects make it significantly easier to understand its link to breast cancer.

What exactly is gestational diabetes?

Gestational diabetes develops during pregnancy and can, when untreated, cause health complications for mother and baby. When a woman has gestational diabetes she will display high blood sugar levels that typically return to normal after the pregnancy. Although any complication during pregnancy can be alarming, it is important to note that gestational diabetes can generally easily be controlled through a healthy diet, regular exercise, and in extreme cases, medication. While gestational diabetes does not necessarily result in serious complications, it is important to be aware of the risks for both mom and baby.

The link between gestational diabetes and breast cancer

Although women with gestational diabetes do not present an increased risk of breast cancer according to studies that have been conducted, it does increase their risk of contracting type 2 diabetes later on. In fact, up to 10% of all women who had gestational diabetes will develop type 2 diabetes according to the National Institutes of Health. This can occur anywhere from within a few weeks after delivery to months or even years later.

Type 2 diabetes proven to increase breast cancer risk

The risk for developing breast cancer is significantly higher among women with type 2 diabetes according to findings published in Diabetes Care. Postmenopausal women above the age of 50 are most at risk with a 27% increased risk of breast cancer. Type 2 diabetes triggers a number of changes in the body such as high insulin level, high glucose levels, and increased inflammation that may increase breast cancer risk. The connection between type 2 diabetes and breast cancer may also be a two-way street as breast cancer survivors could be at an increased risk of developing diabetes following chemotherapy.

Despite gestational diabetes not having a direct impact on breast cancer risk it can, in a more indirect way, increase the risk. By following a healthy lifestyle after a gestational diabetes diagnoses it is possible to reduce the risk of type 2 diabetes later in life which has directly been linked to the onset of breast cancer.