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Rucaparib + Radiation for Breast Cancer

Phase 1

Waitlist Available

Led By Atif Khan, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the duration of study participation

Non-metastatic, histologically or cytologically-confirmed TNBC with evidence of residual disease in the breast or lymph nodes after neoadjuvant chemotherapy

Must not have

Gross residual tumor on imaging or positive margins after breast conserving surgery that are un-excised, as radiation dose in the study will be limited to 60 Gy

Receipt of PARP inhibitor prior to RT

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if a study drug called Rucaparib is safe to be given with a type of radiation therapy that is commonly used to treat women with this form of breast cancer.

Who is the study for?

This trial is for women over 18 with triple negative breast cancer (TNBC) or hormone-receptor positive, Her2/neu negative breast cancer who still have signs of the disease after chemotherapy. They must be able to take oral meds, have a life expectancy of at least 6 months, and good organ function. Women who can get pregnant must use birth control or abstain from sex during the study.

What is being tested?

The trial tests Rucaparib combined with standard radiation therapy on patients with certain types of breast cancer that didn't fully respond to chemotherapy. The goal is to see if this drug plus radiation helps more than just radiation alone.

What are the potential side effects?

Rucaparib may cause side effects like nausea, fatigue, blood count changes, liver enzyme changes, and could potentially affect fertility. Radiation therapy might lead to skin irritation in the treated area and tiredness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am using two birth control methods or am not having sex to avoid pregnancy during the study.

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I have triple-negative breast cancer with remaining signs after chemotherapy.

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My breast cancer is hormone-receptor positive, HER2 negative, and still large or spread to lymph nodes after chemotherapy.

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I had surgery to remove my breast cancer and check the lymph nodes under my arm.

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I am expected to live more than 6 months and can do most of my daily activities.

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I can swallow and keep down pills.

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I am a woman and I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I still have visible tumor or cancer cells at the surgery edge that weren't removed.

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I have taken PARP inhibitors before radiation therapy.

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I have never had radiation therapy on the same side breast or nearby lymph nodes.

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I have not had cancer treatments for at least 2 weeks and any side effects have gone.

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My cancer fully responded to chemotherapy before surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

defining the maximum tolerated dose (MTD)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Rucaparib Administered With RadiationExperimental Treatment2 Interventions

Treatment will consist of rucaparib at one dose level (300 mg BID, 400 mg BID, 500 mg BID or 600 mg BID) concurrently with a 6-week course of radiotherapy and 4 additional weeks of maintenance rucaparib at the same dose level. Radiotherapy will consist of 50 Gy in 2 Gy per fraction to the breast or chest wall with or without regional nodes plus a 10 Gy boost to the lumpectomy cavity, to a total dose of 60 Gy. A 10 Gy boost to the post-mastectomy scar is allowed at the discretion of the treating physician.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiotherapy

2017

Completed Phase 3

~2610

Rucaparib

2016

Completed Phase 3

~2020