A Study of Rucaparib Administered With Radiation in Patients With Triple Negative Breast Cancer With an Incomplete Response Following Chemotherapy

NCT03542175 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 18-002P50CA247749
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Rucaparib; Radiotherapy; Triple Negative Breast Cancer; 18-002

Outcome Measures

Primary Outcomes (1)

• Dose Limiting Toxicities

  Number of Dose Limiting Toxicities encountered at each dose level. The trial will be monitored using TITE-CRM. Assuming a model for the time to occurrence of toxic response as a function of dose, the method allows information from all enrolled patients to be used when allocating a new patient to a dose level.

  1 year

Study Arms (1)

Rucaparib Administered With Radiation

EXPERIMENTAL

one dose level (200 mg BID, 200 mg QD, 300 mg BID, 300 mg QD or 400 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.

Drug: Rucaparib; Radiation: Radiotherapy

Interventions

Rucaparib DRUG

one dose level (200 mg BID, 200 mg QD, 300 mg BID, 300 mg QD or 400 mg BID) concurrently with a 6-week course of radiotherapy and 4 additional weeks of maintenance rucaparib at the same dose level.

Rucaparib Administered With Radiation

Radiotherapy RADIATION

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.

Rucaparib Administered With Radiation

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Breast cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female, ≥ 18 years of age.
• Non-metastatic, histologically or cytologically-confirmed TNBC (defined as ER \<1%, PR \<1%, her-2-neu 0-1+ by IHC or FISH-negative or as per MD discretion), with evidence of residual disease in the breast or lymph nodes after neoadjuvant chemotherapy, at the time of definitive surgical treatment.
• Non-metastatic, histologically or cytologically-confirmed hormone-receptor positive, Her2/neu negative breast cancer (defined as ER \>1% or PR \>1% AND Her-2/neu 0-1+ by IHC or FISH-negative, or as per MD discretion), with evidence of residual grade 3 invasive breast cancer AND either 1) \>5 cm of residual disease in the breast OR 2) ≥ 4 axillary LNs in the axilla after neoadjuvant chemotherapy, at the time of definitive surgical treatment.
• Definitive surgical treatment with breast-conserving surgery or mastectomy and axillary lymph node evaluation.
• At least 6-month life expectancy, ECOG Performance status \< 2.
• Willingness to discontinue any cytotoxic chemotherapeutic agents, and biologic therapy at least 2 weeks prior to the start of RT.
• Adequate organ function (assessed within 30 days prior to initiation of protocol treatment, unless otherwise indicated) as follows:
• Hematology
• Absolute Neutrophil Count (ANC) ≥1500/mm\^3
• Platelet Count ≥100,000/mm\^3
• Hemoglobin ≥9.0 g/dL (after transfusion if required) Renal Function
• Creatinine Serum ≤ 1.5 mg/dL or Creatinine Clearance ≥ 45 mL/min\^a Hepatic Function
• Bilirubin ≤ 1.5 mg/dL
• Aspartate Aminotransferase (AST) ≤ 2.5 x ULN\^b
• Alanine Aminotransferase (ALT) ≤ 2.5 x ULN ULN = upper normal limit of institution's normal range

You may not qualify if:

• 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.
• Complete pathologic response to NAC.
• Receipt of PARP inhibitor prior to RT.
• Pregnant or expecting to conceive within the projected duration of the trial, starting with screening visit through 180 days after the last dose of trial treatment.
• Prior history of radiation therapy to the ipsilateral breast and/or regional nodes is not allowed (prior RT to other sites is permitted).
• Patients with breast augmentation implants are excluded.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to rucaparib.
• Concomitant anti-neoplastic treatment is not allowed during protocol treatment and should be completed at least 2 weeks prior to commencement of protocol treatment, with resolution of associated acute toxicities. Bisphosphonates are permitted without restriction even during protocol treatment. Maintenance pembrolizumab is permitted during the protocol treatment.
• Significant comorbidity: Patients with clinically significant and uncontrolled major disease or disorder that could exacerbate potential toxicities, confound safety assessments, require excluded therapy for management, or limit study compliance.
• Ongoing therapy with other investigational agents. Patients may not be receiving any other investigational agents.
• Unresolved toxicity from other agents. Patients with unresolved CTCAE v4.03 Grade 3 or greater toxicity from prior administration of another investigational drug and/or anti-cancer treatment are not eligible.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Clovis Oncology, Inc.: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (8)

Norwalk Hospital

Norwalk, Connecticut, 06850, United States

Location

Memorial Sloan Kettering at Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Commack

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Interventions

rucaparib; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Dr. Atif Khan, MD
• Organization: Memorial Sloan Kettering Cancer Center

khana7@mskcc.org

848-225-6334

Study Officials

• Atif Khan, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-arm Phase I study.

Study Record Dates

• First Submitted: May 18, 2018
• First Posted: May 31, 2018
• Study Start: May 23, 2018
• Primary Completion: July 25, 2024
• Study Completion: September 10, 2025
• Last Updated: December 8, 2025
• Results First Posted: December 8, 2025

Record last verified: 2025-09

Locations

US (8)