CLINICAL TRIAL

nivolumab for Breast Cancer

Grade II
Waitlist Available · 18+ · All Sexes · Chattanooga, TN

This study is evaluating whether a drug may help treat breast cancer.

See full description

About the trial for Breast Cancer

Eligible Conditions
Breast Neoplasms · Breast Cancer

Treatment Groups

This trial involves 2 different treatments. Nivolumab is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
cyclophosphamide
DRUG
nivolumab
BIOLOGICAL
paclitaxel (PTX)
DRUG
anthracycline
DRUG
Endocrine Therapy
DRUG
Surgery
PROCEDURE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
cyclophosphamide
DRUG
nivolumab placebo
OTHER
paclitaxel (PTX)
DRUG
anthracycline
DRUG
Endocrine Therapy
DRUG
Surgery
PROCEDURE

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
FDA approved
Nivolumab
FDA approved
Endocrine Therapy
2013
Completed Phase 2
~160
Surgery
1999
Completed Phase 3
~2060

Eligibility

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Localized invasive breast ductal carcinoma, confirmed by the local pathologist, that includes the following combined primary tumor and clinical node (cN) categories: T1c (tumor size = 2 cm)-T2 (tumor size > 2 cm), cN1-N2 OR T3-T4, cN0-cN2. Note: Axillary lymph node status must be assessed by fine needle biopsy or core biopsy.
Tumor Grade 3 of ductal histology, Or Tumor Grade 2 of ductal histology having an ER expression level percentage between 1-10%
You must agree to provide primary breast tumor tissue at baseline and at surgery. show original
Must be deemed eligible for surgery
Males and females must agree to follow specific methods of contraception, if applicable, while participating in the trial
You have estrogen receptor-positive (ER+) breast cancer (BC) and you have or do not have progesterone receptor (PgR) expression (determined on the most recently analyzed tissue sample tested locally and confirmed by the central laboratory, as defined in the relevant American Society of Clinical Oncology (ASCO)- College of American Pathologists (CAP) Guidelines. show original
You have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. show original
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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: up to 10 years
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 10 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: up to 10 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 nivolumab will improve 2 primary outcomes and 12 secondary outcomes in patients with Breast Cancer. Measurement will happen over the course of up to 52 weeks.

Change from baseline on the EORTC QLQ-C30 physical functioning subscale (items 1 to 5)
UP TO 52 WEEKS
UP TO 52 WEEKS
Change from baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) global health status/quality of life (QOL) subscale (items 29 and 30)
UP TO 52 WEEKS
UP TO 52 WEEKS
Residual cancer burden (RCB) category status (0, I, II, III)
APPROXIMATELY 7 MONTHS
APPROXIMATELY 7 MONTHS
ORR using definition of tumor response rate per clinic-based physical assessment
APPROXIMATELY 7 MONTHS
APPROXIMATELY 7 MONTHS
pCR using the definition of ypT0 ypN0
APPROXIMATELY 7 MONTHS
APPROXIMATELY 7 MONTHS
Objective response rate (ORR) using definition of tumor response rate per radiologic-based assessment
APPROXIMATELY 7 MONTHS
APPROXIMATELY 7 MONTHS
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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 common treatments for breast cancer?

The common treatments for breast cancer include surgery, chemotherapy, hormone therapy including hormonal deprivation, radiation therapy, and targeted treatment. The common treatment varies depending on the stage of the disease.\n

Anonymous Patient Answer

What causes breast cancer?

Breast cancer seems to derive from an interaction between different genetic changes occurring over many years, many of which are lifestyle or environmental factors. The main cancer sites are the breast, breast fat and skin and the colorectum. There is the potential to prevent most breast cancer by avoiding a number of environmental risk factors and by using screening or early diagnosis to detect the disease at an early stage. Preventing breast cancer also requires effective treatments, particularly estrogen-targeted agents, and advances in understanding the tumour marker, CA15-3, and in the diagnosis of breast cancer.

Anonymous Patient Answer

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

In 2011 a population-based cohort of US women aged ≤ 50 years with primary tumor of the breast was identified through the SEER database. The most frequent sites of occurrence were the skin and the breast. The annual age-adjusted cumulative incidence was calculated for non-Hispanic whites, Hispanics, black (non-Hispanic), and other race/ethnicity, and the age-adjusted annual cancer death rate was calculated for non-Hispanic whites. The data suggested a slightly increased risk among non-Hispanic whites compared with blacks of all ethnicity, a similar risk among non-Hispanic blacks compared with other races, and no difference between Hispanics and other race/ethnicity.

Anonymous Patient Answer

Can breast cancer be cured?

There are various breast cancer treatments that can be effective. All treatments are a part of a comprehensive plan that takes into account risks, benefits, lifestyle, emotional adjustment, and quality of life.

Anonymous Patient Answer

What is breast cancer?

Breast cancer makes up one in 10 of all [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) deaths. It is caused by the fact that in most women, breast tissue contains cells that can become cancerous when mutated with a gene named "BRCA1" (breast cancer susceptibility gene 1). In other women, a BRCA1 protein deficiency can lead to breast, ovarian, or other cancer formation. When breast cancer forms, it usually comes as a fast-growing, swollen lump on the surface of the breast. Breast cancer is a form of abnormal cell growth. It is treated both through surgery to remove the lump as well as through chemotherapy and some hormonal treatments.

Anonymous Patient Answer

What are the signs of breast cancer?

Signs of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) include lump in the breast or breast duct, nipple discharge, pain, nipple retraction or inverted nipple and scaly or itchy skin. Women should be aware of the symptoms and may have an underlying reason that the symptoms might not be breast cancer. Women should visit a health professional if they do not resolve after 2–3 years.

Anonymous Patient Answer

Has nivolumab proven to be more effective than a placebo?

The response rate observed at a month 3 is at least as good and at least as durable as a PFS for patients who received at least one dose of nivolumab monotherapy.

Anonymous Patient Answer

What is the latest research for breast cancer?

We need to have more women involved in all aspects of the research process, including funders, peer reviewers, editors, authors, readers, and students, and to have the research published in journals with the highest editorial standards. We have to use evidence-based medicine to help us understand how best to diagnose, treat, and provide support for breast cancer victims, but we need to be able to translate that evidence into practice by applying it to current survivors and their families alike. We need to have research that leads to better patient outcomes, not “bland” and “me-too” outcomes that serve only as “flashes in a pan”.

Anonymous Patient Answer

What are the common side effects of nivolumab?

Serious adverse effects were rare both in patients receiving nivolumab for refractory or metastatic breast cancer. The most common adverse events in patients receiving nivolumab were fatigue (15.1%), headache (5.6%), and diarrhea (5.1%). Anemia was the most often cited cause in patients who had to stop or reduce their dose of nivolumab (5.6%).

Anonymous Patient Answer

Who should consider clinical trials for breast cancer?

Clinical trial enrolment should be based on the patient's preferences, with consideration that they may wish to be approached about a trial before and/or during diagnosis. This trial may benefit only a limited proportion of patients with advanced breast cancer. Clinical trials may be for patients at high risk of relapse or for surrogate or prognostic biomarkers of outcome.

Anonymous Patient Answer

How quickly does breast cancer spread?

Recent findings demonstrates that the most rapidly growing cancer in women is invasive [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer). In recent decades, we find a significant increase in the size of invasive breast cancer. Further, this study highlights the potential for earlier detection due to the recent rapid increase in the use of mammography and ultrasonography to identify breast lesions.

Anonymous Patient Answer

What are the latest developments in nivolumab for therapeutic use?

Nivolumab is being increasingly used in the treatment of metastatic [metastatic breast cancer](https://www.withpower.com/clinical-trials/metastatic-breast-cancer) (MMBC). The high response rate and favourable toxicity profile make it an asset for patients with MMBC in our experience. However, it is not approved for use in combination with paclitaxel and carboplatin for the first-line treatment of advanced breast cancer due to the high incidence of gastrointestinal toxicity..

Anonymous Patient Answer
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