Pembrolizumab for Male Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Levine Cancer Institute, Charlotte, NC
Male Breast Cancer+3 More
Pembrolizumab - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a combination of chemotherapy and immunotherapy is safe and feasible.

See full description

Eligible Conditions

  • Male Breast Cancer
  • Breast - Female

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

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

18 weeks
Grade 3 or 4 treatment-related adverse event
2 years
Disease control rate
Duration of response
Objective response rate
Overall survival
Progression-free survival

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Cohort A
1 of 2
Cohort B
1 of 2
Experimental Treatment

This trial requires 40 total participants across 2 different treatment groups

This trial involves 2 different treatments. Pembrolizumab is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Cohort APaclitaxel will be given as an IV infusion over 60 minutes, on days 1 and 8 every 21 (+/- 3) days during Cycles 1 and 2. No pembrolizumab will be given during Cycles 1 and 2. Starting with cycle 3 and subsequent cycles, pembrolizumab will be given as an IV infusion over 30 minutes before paclitaxel on day 1 every 21 (+/- 3) days.
Cohort BPembrolizumab will be given as an IV infusion on day 1 before paclitaxel every 21 (+/- 3) days. Paclitaxel will be given as an IV infusion over 60 minutes, on days 1 and 8 every 21 (+/- 3) days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Paclitaxel
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 2 years for reporting.

Closest Location

Levine Cancer Institute - Charlotte, NC

Eligibility Criteria

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.

Mark “yes” if the following statements are true for you:
Histologically or cytological confirmed diagnosis of HER2-negative metastatic breast cancer or locally advanced disease not amenable to resection.
Available ER and PR status from tumor sample with either hormone receptor positive or negative tumor(s).
For subjects with hormone receptor-positive, HER2-negative metastatic breast cancer, they are eligible if they have already received or been intolerant to at least two lines of endocrine therapies (including the adjuvant and/or metastatic setting), or are appropriate candidates for chemotherapy (i.e. large burden of visceral disease).
Measurable disease by RECIST 1.1, or evaluable bone disease, i.e., bone lesions that are lytic or mixed (i.e. lytic + sclerotic) in the absence of measurable lesion. Refer to section 11 for the evaluation of measurable disease.
Male or female age ≥18 years.
ECOG performance status 0, 1 or 2.
Hematologic - Absolute neutrophil count ≥1,500/mcL
- Platelets ≥75,000/mcL
- Hemoglobin ≥ 9 g/dL
Renal

Patient Q&A Section

Can breast cancer be cured?

"Unfortunately, no randomized clinical trial exists with a focus on tumor cells. For this reason, a randomized, definitive, long-term study of prophylactic, chemo- or radiation-based breast cancer therapy has yet to be conducted. For the time being, it appears that there are no cures in oncology." - Anonymous Online Contributor

Unverified Answer

What is breast cancer?

"Breast is a cancer of the outer layer of the body that forms in tissues which lie close to the skin and connect the nipple to the outer layer of the body, the breast. It is the third most common cause of death and the most common form of cancer in women. Cancer treatment can be used to extend the life expectancy of some individuals and alter the course of the disease in others. Breast cancer remains a significant health hazard for women in most countries." - Anonymous Online Contributor

Unverified Answer

What are the signs of breast cancer?

"Signs of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) include: lump, nipple discharge, skin change, loss of appetite, feeling unwell, feeling tired and weight loss. Breast cancers are typically discovered on a regular examination by a medical professional, or through X-ray. If the diagnosis is suspected, doctors would examine or biopsy a portion of the breast and send it to a pathologist for diagnosis.\n" - Anonymous Online Contributor

Unverified Answer

What causes breast cancer?

"The causal links between [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) and some environmental factors, such as alcohol consumption and diet, are known. But the exact reasons for their link with breast cancer may not be completely clear. Moreover, the risk factors for breast cancer, such as the age at menarche, the use of oral contraceptives, and the intake of tobacco products may partly determine whether breast cancer appears, depending on the particular cancer type that develops. The environmental factors associated with breast cancer may also vary with breast cancer subtype." - Anonymous Online Contributor

Unverified Answer

What are common treatments for breast cancer?

"The common treatments for breast cancer were: mastectomy; chemotherapy: taxanes; targeted therapy, aromatase inhibitor (AI), hormone therapy (HT); and surgery. Of these, mastectomy is the most common, used in 40 percent of patients. Chemotherapy was used by 24 percent: taxanes in 19 percent; AIs in 13 percent; HT in 8 percent; and surgery in 7 percent of patients. Other less-common treatments that were used included palliative care, trastuzumab, radiotherapy, and targeted therapy in 3% of patients." - Anonymous Online Contributor

Unverified Answer

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

"Breast cancer incidence rates have increased by more than 1,000% (from 1 in 26,000 to 1 in 9,000) in the United States from 1969 to 2008. The most recent data from the National Breast and Cervical Cancer Early Detection Program (NBDCP) suggest that 1 in 3,000 women will develop [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) during her lifetime and that 1 in 300,000 will die from the disease over a lifetime. These estimates represent an increase in the number of Americans diagnosed with breast cancer since 1975, and an increased number of women diagnosed with localized disease and who live to see their first cancer diagnoses. As many as 83% of women diagnosed with breast cancer may never recur." - Anonymous Online Contributor

Unverified Answer

What is pembrolizumab?

"The antitumor activity of pembrolizumab in combination with neoadjuvant chemotherapy in HER2-positive breast cancer was demonstrated. Clinically, significant objective response rates were seen with pembrolizumab in combination with neoadjuvant chemotherapy." - Anonymous Online Contributor

Unverified Answer

Does pembrolizumab improve quality of life for those with breast cancer?

"There was no improvement in the quality of life of metastatic breast cancer patients treated with pembrolizumab plus placebo beyond what could be expected as a result of improved response rates as demonstrated in RECIST studies." - Anonymous Online Contributor

Unverified Answer

Has pembrolizumab proven to be more effective than a placebo?

"In patients with metastatic breast cancer, the addition of pembrolizumab to capecitabine resulted in a significantly longer PFS than placebo after 2 years of treatment." - Anonymous Online Contributor

Unverified Answer

Does breast cancer run in families?

"Breast cancer is more common among sisters of women with a diagnosis of breast cancer than among controls. This difference persisted after adjustment for familial aggregation in the incidence of breast cancer." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of breast cancer?

"There are at least two theories regarding the leading cause of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer). The prevailing theory suggests that environmental exposures play a major role in breast cancer development, while the other theory asserts that genetic mutations are the leading cause of breast cancer. The primary cause of breast cancer remains unknown; however, it is likely that various environmental and biological causes act together to cause carcinogenesis. (1) Breast self-examination (BSE), when done monthly or yearly, can be used for early detection of breast and cervical cancer." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating breast cancer?

"None are as yet available. In general, we must depend on the existing treatments and hope that new medicines will be developed. We certainly will get more information as time goes on and people with the disease seek treatment options. But even if we can do nothing else, we must keep our patients informed and find ways to make them easier in their recovery process." - Anonymous Online Contributor

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