Study on Nivolumab, Ipilimumab, and Bicalutamide for HER2 Negative Breast Cancer Patients
Sponsor: Providence Health & Services
ClinicalTrials ID:NCT03650894
This clinical trial is testing a new combination of treatments that may help control advanced HER2-negative breast cancer without using chemotherapy right away. The study combines two types of immune therapies with a hormone therapy to see if they can work together to treat the cancer effectively.
Patient Parameters
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Program Overview
The aim of this study is to test the safety and effectiveness of a new treatment combination for advanced HER2-negative breast cancer. This approach uses two immune therapies, nivolumab and ipilimumab, along with a hormone therapy called bicalutamide. The goal is to see if this combination can help control the cancer without needing chemotherapy immediately.
Description
This study is for adult women with advanced HER2-negative breast cancer that cannot be removed by surgery. It includes women with triple-negative breast cancer if their tumors have a specific marker called the androgen receptor (AR). Participants should not have had more than one previous chemotherapy treatment for cancer that cannot be cured.
Participants will receive:
- Nivolumab (an immune therapy) through an IV every two weeks.
- Ipilimumab (another immune therapy) through an IV every six weeks.
- Bicalutamide (a hormone therapy) as a daily pill.
The treatment will continue for up to 24 months unless the cancer progresses or side effects become too severe. After 24 months, if the cancer is still responding, participants may stop the immune therapies but can continue bicalutamide if the doctor agrees. If the cancer progresses later, participants may have the option to restart treatment.
Eligibility Criteria
Inclusion Criteria
- Women aged 18 or older with advanced HER2-negative breast cancer.
- Must have a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Triple-negative breast cancer patients must have AR positivity confirmed.
- Must have measurable cancer according to specific criteria.
- Must be willing to provide a tumor sample if possible.
- Must not have had more than one previous chemotherapy treatment for cancer that cannot be cured.
- Must agree to follow study procedures and attend scheduled visits.
- Must have adequate blood and liver function.
- Must not be pregnant or breastfeeding and agree to use birth control during and for five months after treatment.
Exclusion Criteria
- Active or untreated brain metastases unless treated and stable.
- Any other active cancer within the last three years, except for certain skin cancers or cervical cancer.
- Serious medical conditions that could increase risks or interfere with the study.
- Recent major surgery or significant injury.
- Active autoimmune diseases, except for certain stable conditions.
- Need for high-dose steroids or other immune-suppressing medications.
- Severe heart failure.
- Unresolved side effects from previous cancer treatments.
- HIV or AIDS.
- Active infections or other serious illnesses.
- History of certain lung diseases or bowel conditions.
- Active hepatitis B or C.
- Allergies to study drugs.
- Previous treatment with similar immune therapies or androgen receptor blockers.
- Participation in another clinical trial within the last four weeks.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
| Providence Oncology & Hematology Care Clinic - Eastside | 97213 | Portland | Oregon |
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