31 Participants Needed

Rucaparib + Radiation for Breast Cancer

Recruiting at 8 trial locations
AK
Simon Powell, MD, PhD profile photo
Overseen BySimon Powell, MD, PhD
Age: 18+
Sex: Female
Trial Phase: Phase 1
Sponsor: Memorial Sloan Kettering Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to test the safety of a study drug called Rucaparib, administered in combination with the type of radiation therapy that is usually given to women with your form of breast cancer.

Will I have to stop taking my current medications?

The trial requires participants to stop taking any cytotoxic chemotherapeutic agents and biologic therapy at least 2 weeks before starting radiation therapy. However, bisphosphonates and maintenance pembrolizumab are allowed during the trial.

Is the combination of Rucaparib and Radiation therapy safe for humans?

Rucaparib has been studied for safety in humans, particularly in patients with ovarian and breast cancers with BRCA mutations. It is generally considered safe, but like many cancer treatments, it can have side effects. When combined with radiation therapy, it has shown potential in treating cervical cancer, suggesting it may be safe for use in combination with radiation, but more research is needed to confirm this for breast cancer specifically.12345

What makes the Rucaparib + Radiation treatment for breast cancer unique?

Rucaparib + Radiation for breast cancer is unique because it combines a PARP inhibitor (Rucaparib) with radiation therapy, potentially enhancing the effectiveness of radiation by making cancer cells more sensitive to it. This combination is different from other treatments that typically use chemotherapy drugs or hormone therapies with radiation.678910

What data supports the effectiveness of the drug Rucaparib combined with radiation therapy for breast cancer?

Research shows that combining PARP inhibitors, like Olaparib, with radiation can make cancer cells more sensitive to treatment, improving outcomes in certain cancers. This suggests that Rucaparib, another PARP inhibitor, might also enhance the effectiveness of radiation therapy in breast cancer.610111213

Who Is on the Research Team?

Atif Jalees Khan, MD, MS - MSK ...

Atif Khan, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

If you are a woman who could become pregnant, you need to have a negative pregnancy test within the 14 days before starting the study treatment.
I am using two birth control methods or am not having sex to avoid pregnancy during the study.
I have triple-negative breast cancer with remaining signs after chemotherapy.
See 8 more

Exclusion Criteria

I still have visible tumor or cancer cells at the surgery edge that weren't removed.
I have taken PARP inhibitors before radiation therapy.
I have never had radiation therapy on the same side breast or nearby lymph nodes.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Rucaparib is administered concurrently with a 6-week course of radiotherapy, followed by 4 additional weeks of maintenance rucaparib

10 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

  • Radiotherapy
  • Rucaparib
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Rucaparib Administered With RadiationExperimental Treatment2 Interventions

Radiotherapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

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Approved in European Union as Radiation therapy for:
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Approved in United States as Radiation therapy for:
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Approved in Canada as Radiation therapy for:
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Approved in Japan as Radiation therapy for:
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Approved in China as Radiation therapy for:
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Approved in Switzerland as Radiation therapy for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Clovis Oncology, Inc.

Industry Sponsor

Trials
65
Recruited
11,100+

Patrick J. Mahaffy

Clovis Oncology, Inc.

Chief Executive Officer since 2009

BA from Haverford College, MBA from Columbia University

Lindsey Rolfe

Clovis Oncology, Inc.

Chief Medical Officer since 2015

Specialist accreditation in pharmaceutical medicine

Published Research Related to This Trial

Combining chemotherapy with radiation therapy has shown significant clinical advancements in cancer treatment, particularly through the use of systemic therapies that can enhance tumor control (radiosensitization) and reduce damage to healthy tissues (radioprotection).
Recent early-phase clinical trials have focused on identifying effective combinations of systemic agents with radiation, suggesting that using surrogate endpoints, like active drug metabolites in tumors, could help streamline the search for optimal treatment schedules, although more robust Phase III trials are still needed.
New and emerging radiosensitizers and radioprotectors.Spalding, AC., Lawrence, TS.[2007]
Ribociclib, a CDK4-6 inhibitor, has been approved as a first-line treatment for metastatic breast cancer, showing significant improvement in progression-free survival compared to endocrine therapy alone.
Preliminary data from five patients treated with ribociclib and palliative radiotherapy suggest a need for further investigation into the safety and efficacy of this combination, as ribociclib has a challenging toxicity profile.
Ribociclib plus letrozole and concomitant palliative radiotherapy for metastatic breast cancer.Meattini, I., Desideri, I., Scotti, V., et al.[2022]
NanoOlaparib, a lipid-based formulation of the PARP inhibitor olaparib, significantly enhances the sensitivity of radiation-resistant prostate cancer cells and tumors, leading to improved tumor growth inhibition compared to traditional oral olaparib.
In a mouse model, combining NanoOlaparib with radiation not only tripled median survival time but also resulted in a complete response in half of the treated mice, indicating its potential as a powerful strategy for treating tumors with PTEN and TP53 deletions.
Nanoformulation of Olaparib Amplifies PARP Inhibition and Sensitizes PTEN/TP53-Deficient Prostate Cancer to Radiation.van de Ven, AL., Tangutoori, S., Baldwin, P., et al.[2022]

Citations

New and emerging radiosensitizers and radioprotectors. [2007]
Olaparib enhances sensitization of BRCA-proficient breast cancer cells to x-rays and protons. [2023]
Combination of sunitinib, cetuximab and irradiation in an orthotopic head and neck cancer model. [2020]
Ribociclib plus letrozole and concomitant palliative radiotherapy for metastatic breast cancer. [2022]
Nanoformulation of Olaparib Amplifies PARP Inhibition and Sensitizes PTEN/TP53-Deficient Prostate Cancer to Radiation. [2022]
PARP Inhibitors for Cancer Therapy. [2022]
Breast cancer resistance protein (BCRP/ABCG2) and P-glycoprotein (P-GP/ABCB1) restrict oral availability and brain accumulation of the PARP inhibitor rucaparib (AG-014699). [2021]
Non-BRCA DNA Damage Repair Gene Alterations and Response to the PARP Inhibitor Rucaparib in Metastatic Castration-Resistant Prostate Cancer: Analysis From the Phase II TRITON2 Study. [2021]
The poly (ADP-ribose) polymerase inhibitor rucaparib suppresses proliferation and serves as an effective radiosensitizer in cervical cancer. [2020]
Phase 2 multicentre trial investigating intermittent and continuous dosing schedules of the poly(ADP-ribose) polymerase inhibitor rucaparib in germline BRCA mutation carriers with advanced ovarian and breast cancer. [2018]
Prospective results of concurrent radiation therapy and weekly paclitaxel as salvage therapy for unresectable locoregionally recurrent breast cancer. [2020]
Concurrent radiotherapy with palbociclib or ribociclib for metastatic breast cancer patients: Preliminary assessment of toxicity. [2020]
13.United Statespubmed.ncbi.nlm.nih.gov
Prospective evaluation of concurrent paclitaxel and radiation therapy after adjuvant doxorubicin and cyclophosphamide chemotherapy for Stage II or III breast cancer. [2015]
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