Berzosertib + Radiation for Triple-Negative Breast Cancer

Recruiting in Palo Alto (17 mi)

+14 other locations

Overseen byRobert W Mutter

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial studies the best dose of berzosertib combined with radiation therapy for treating certain types of breast cancer. Berzosertib helps stop cancer cell growth by blocking important enzymes, while radiation kills the cancer cells. This combination may work better than radiation alone.

Eligibility Criteria

Adults over 18 with certain types of breast cancer (triple-negative or hormone receptor-positive, HER2-negative) that didn't respond to chemotherapy can join. They must have completed surgery and possibly postoperative chemo recently, be in good health otherwise, and agree to use contraception. People with recent chemo, prior radiation in the same area, uncontrolled illnesses, or known hypersensitivity to similar drugs are excluded.

Inclusion Criteria

I had immediate reconstruction after my mastectomy.

My breast cancer is triple-negative or has low hormone receptor levels, and I've had specific chemotherapy.

I am not pregnant or able to become pregnant, and will use birth control during and after the study.

See 19 more

Exclusion Criteria

I have recovered from previous cancer treatment side effects, except for hair loss and mild nerve pain.

I have not had chemotherapy in the last 4 weeks.

You had allergic reactions to drugs similar to berzosertib.

See 8 more

Treatment Details

Interventions

Berzosertib (ATR Inhibitor)
Radiation Therapy (Radiation)

Trial OverviewThe trial is testing Berzosertib combined with standard radiation therapy against breast cancer that resisted chemotherapy. It aims to find the best dose of Berzosertib which blocks enzymes needed for cell growth and may enhance the effectiveness of radiation therapy.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (berzosertib, radiation therapy)Experimental Treatment5 Interventions

Patients receive berzosertib IV over 60 minutes BIW for 5 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo RT 5 days a week for 5-6 weeks depending on the type of surgery undergone. Patients also undergo a collection of blood on study.

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

🇪🇺 Approved in European Union as Radiation Therapy for: