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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 am willing to stop any cancer-killing drugs or biological treatments 2 weeks before starting radiation therapy.
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My blood, kidney, and liver functions are all within normal ranges.
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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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
defining the maximum tolerated dose (MTD)

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
Rucaparib
2016
Completed Phase 3
~1990
Radiotherapy
2017
Completed Phase 3
~2610

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,928 Previous Clinical Trials
591,777 Total Patients Enrolled
202 Trials studying Breast Cancer
95,138 Patients Enrolled for Breast Cancer
Clovis Oncology, Inc.Industry Sponsor
63 Previous Clinical Trials
10,140 Total Patients Enrolled
2 Trials studying Breast Cancer
313 Patients Enrolled for Breast Cancer
Atif Khan, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
3 Previous Clinical Trials
120 Total Patients Enrolled
2 Trials studying Breast Cancer
94 Patients Enrolled for Breast Cancer

Media Library

Radiotherapy Clinical Trial Eligibility Overview. Trial Name: NCT03542175 — Phase 1
Breast Cancer Research Study Groups: Rucaparib Administered With Radiation
Breast Cancer Clinical Trial 2023: Radiotherapy Highlights & Side Effects. Trial Name: NCT03542175 — Phase 1
Radiotherapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT03542175 — Phase 1

Frequently Asked Questions

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

How efficacious is Rucaparib for individuals seeking medical aid?

"The safety profile of Rucaparib is estimated to be a 1 since this trial only exists in the early stages. There is limited information available regarding both efficacy and security."

Answered by AI

Can you elaborate on any other research projects that have been conducted utilizing Rucaparib?

"Rucaparib was initially investigated in 2015 at The Royal Marsden NHS Foundation Trust located in Downs Road, Sutton. Since that seminal moment of discovery there have been 157 concluded clinical trials and 34 ongoing studies, the majority of which are being conducted out of Norwalk, Connecticut."

Answered by AI

Is this research a pioneering endeavor?

"Rucaparib has been the focus of 34 distinct clinical trials in 831 cities and 34 nations since Clovis Oncology, Inc. initiated its Phase 2 drug approval process with a trial involving 924 participants back in 2015; these experiments have cumulatively included over 150 separate studies."

Answered by AI

Is this research investigation accepting participants?

"Clinicaltrials.gov divulges that this clinical investigation is currently not accepting volunteers, despite having been initially posted on May 23rd 2018 and last modified on August 31st 2022. Though the trial isn't open to enrollments at present, there are 2,697 other trials actively searching for study participants."

Answered by AI

How many venues are currently managing this experiment?

"Presently, this study has 8 enrolment sites distributed across Norwalk, New york and Commack. It is recommended to choose the closest one to save time on travelling should you decide to join in."

Answered by AI

What is the upper bound of participants for this trial?

"This study is currently not setting forth to look for participants. As it was initially posted on May 23, 2018 and last updated August 31 2022, other trials may be more suitable. There are 2663 clinical studies actively seeking patients with breast cancer while 34 research projects involving Rucaparib are presently hosting enrolments."

Answered by AI
~1 spots leftby Jul 2024