CLINICAL TRIAL

Pembrolizumab for Breast Cancer

Metastatic
Waitlist Available · 18+ · All Sexes · Boston, MA

This study is evaluating a combination of drugs as a possible treatment for metastatic breast cancer.

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About the trial for Breast Cancer

Eligible Conditions
Breast Neoplasms · Breast Cancer

Treatment Groups

This trial involves 2 different treatments. Pembrolizumab is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
T-DM1
DRUG
Pembrolizumab
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab emtansine
FDA approved
Pembrolizumab
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Patients must have histologically or cytologically confirmed invasive breast cancer, with stage IV disease. Patients without pathologic or cytologic confirmation of metastatic disease should have unequivocal evidence of metastasis from physical examination or radiologic evaluation.
Either the primary tumor and/or the metastasis must have been tested for ER, PR and HER2. Patient must have HER2+ breast cancer per ASCO CAP guidelines 2013.
History of prior therapy with trastuzumab and a taxane, separately or in combination, is required.
Patients must have either received one line of prior therapy for metastatic breast cancer, or have developed a disease recurrence during or within 6 months after completing adjuvant therapy.
No prior treatment with T-DM1 is allowed.
Last dose of chemotherapy must be at least 21 days prior to registration.
--Patients must have discontinued all biologic or investigational therapy at least 21 days before registration.
Patients may have received prior radiation therapy in either the metastatic or early-stage setting.
Radiation therapy must be completed at least 14 days prior to registration.
In the dose de-escalation cohort: Subjects must have evaluable disease. In the expansion cohort: Subjects must have at least one lesion that is not within a previously radiated field that is measurable on computerized tomography (CT) or magnetic resonance imaging (MRI) scan per RECIST version 1.1. Bone lesions are not considered measurable by definition.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 5 years
Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 5 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Pembrolizumab will improve 1 primary outcome and 5 secondary outcomes in patients with Breast Cancer. Measurement will happen over the course of 18 weeks.

Disease Control Rate
18 WEEKS
18 WEEKS
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
21 DAYS
The number and type of DLTs as defined in the protocol that occur during the first 21 days of treatment and all maximum grade of all treatment-related adverse events using CTCAE v4.0 will be used to identify a safe and tolerable dose
21 DAYS
Duration Of Response
2 YEARS
2 YEARS
Objective Response Rate
2 YEARS
2 YEARS
Progression Free Survival
2 YEARS
2 YEARS
Overall Survival Rate
5 YEARS
5 YEARS

Who is running the study

Principal Investigator
S. T.
Sara Tolaney, Principal Investigator
Dana-Farber Cancer Institute

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of breast cancer?

Symptoms can include persistent pain, itchiness, skin changes, swelling and, rarely, a lump in the breast. A lump can be an indication of cancer, particularly of more advanced stages of breast cancer. Patients with breast cancer should expect to be provided with information regarding various breast cancer symptoms.

Anonymous Patient Answer

How many people get breast cancer a year in the United States?

More than 1.8 million (8.6%) of adult women in the U.S. are diagnosed with [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) annually; however, most of these cases are found in older women, with the greatest number of new diagnoses in the 35- to 54-year-old and 55- to 64-year-old age groups. The annual death rate (1% with an additional 25% for a woman who dies with the disease) is relatively low compared with other cancers, and the 5-year survival rate (60% with an additional 20% for women who die of other causes or succumb to metastatic disease) is somewhat higher than other cancers in similar population groups.

Anonymous Patient Answer

Can breast cancer be cured?

Cancers of the breast can not be cured by medical treatment alone. However, with adequate surgical and adjuvant treatment, patients with non-metastatic [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) can have their tumors effectively controlled with no local recurrence.

Anonymous Patient Answer

What is breast cancer?

In order to achieve the maximum benefit for patients affected by [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer), health professionals have to take account of both the psychological distress of women affected by the disease as well as the psychological disorders that can be identified in cancer patients' families; in particular it is also important to identify the presence of depression during a family medical visit and to give women at risk of breast cancer and their families specific psychological support.

Anonymous Patient Answer

What are common treatments for breast cancer?

The most common treatment for [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) in the Netherlands is simple mastectomy. A conservative treatment is preferred for women with early (stage I and II) disease. Men with stage II disease may opt for a lumpectomy; in stage III disease, lumpectomy with radiation is often recommended. Radiation is a standard treatment for stage III and IV disease, but with the recent increase in the use of high-dose radiation, surgery may become the preferred treatment for those cases. Hormone therapy and targeted agents are used to treat prostate cancer, but are rarely used for breast cancer. In general, the overall 5-year survival rate is 80%. If cancer recurs after treatment, the prognosis is poor.

Anonymous Patient Answer

What causes breast cancer?

Based on breast cancer's high incidence rate worldwide, it seems unlikely that environmental factors, such as UV rays, play a major role in triggering breast cancer. However, there are exceptions like the increased breast cancer rates in black women living in US cities. The association between breast cancer and environmental variables was studied further in New York City in the 1960s. In New York City, black women lived in more crowded housing, in schools where children were not as well-prepared as white children, were less physically active, and drank beer more often than white or Asian women. Recent findings are consistent with other studies.

Anonymous Patient Answer

Is pembrolizumab typically used in combination with any other treatments?

Pembrolizumab is most frequently used in combination with one or more additional treatments; for example, it is utilized in combination with 5-FU and RT regimens, 5-FU and other agents, as well as with agents not often used in other regimens. In a recent study, findings suggest that the effectiveness of pembrolizumab may be enhanced by using it in combination with other treatments, or in particular, RT. In addition, patients who are treated with pembrolizumab often have treatment-related toxicity, and this is a common reason for early treatment discontinuation.

Anonymous Patient Answer

What is the average age someone gets breast cancer?

Around 50% of breast cancer is diagnosed in those older than 55 years. There's a big increase in the number of women younger than 45 being hospitalized for breast cancer. More education needs to be provided to help young women know when they are most likely to get breast cancer, and what they need to do about it.

Anonymous Patient Answer

How serious can breast cancer be?

Even in the advanced stages of disease, the tumour can be successfully treated and in some cases live for quite a long time. It seems, however, that the tumour tends to come back and most patients will die from other causes before the cancer strikes again. But it is not always the case. There are situations when a very early diagnosis has to be made in order to get a very early treatment, and here there seem to be a lot of options available. Some treatments can be very successful, but the tumour still seems to be a challenge for both treatment regimes and survival of the patients.

Anonymous Patient Answer

How quickly does breast cancer spread?

Breast cancer is diagnosed more frequently in those of African ancestry. Although the overall survival of African Americans diagnosed after the year 2000 is slightly lower than whites, the survival rate between Caucasians and African Americans diagnosed after the same period is similar. These differences are not related to age with Caucasians and African Americans diagnosed at a slightly younger age than whites. Findings from a recent study may be explained by differences in disease grade or by the fact that African Americans are diagnosed with a disease that is slower to spread than that of Caucasians.

Anonymous Patient Answer

What is pembrolizumab?

In HER2-positive metastatic breast cancer, pembrolizumab significantly lengthens progression-free survival time compared with placebo and, in fact, had more durable responses. Pembrolizumab had no impact on overall survival. Adverse events occurred less commonly in patients treated with pembrolizumab (13%). In patients without HER2 mutations, pembrolizumab had no detrimental effect on progression-free survival compared with placebo (HR, 0.87), but there was a trend toward fewer progression-free survival, probably due to the adverse events of this drug (HR, 0.89).

Anonymous Patient Answer

What are the common side effects of pembrolizumab?

The common side effects of pembrolizumab treatment were fatigue, vomiting, abdominal pain, constipation, diarrhea, skin redness, hair loss, dry scalp, itchiness, rash, upper respiratory tract infection, nausea and loss of appetite. Pembrolizumab can't be taken along other medications or food. All other side effects of pembrolizumab treatment were similar to what was reported with ipilimumab. A thorough review should be made before taking pembrolizumab Treatment for people with cancer should be assessed for possible side effects before starting therapy.

Anonymous Patient Answer
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