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NCT03542175

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

Completed Phase 1 Results posted Last updated 8 December 2025
What this trial tests

Phase 1 trial testing Rucaparib in Breast Cancer in 31 participants. Completed in 10 September 2025.

Timeline
23 May 2018
Primary endpoint
25 July 2024
10 September 2025

Quick facts

Lead sponsorMemorial Sloan Kettering Cancer Center
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment31
Start date23 May 2018
Primary completion25 July 2024
Estimated completion10 September 2025
Sites8 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Memorial Sloan Kettering Cancer Center — full company profile →

Who can join

18 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Dose Limiting Toxicities Primary · 1 year

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.

GroupValue95% CI
Rucaparib 200 mg BID1
Rucaparib 200 mg QD0
Rucaparib 300 mg BID3
Rucaparib 300 mg QD3
Rucaparib 400 mg BID1

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 year. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Rucaparib 200 mg BID
Serious: 0/2 (0%)
Deaths: 1/2
Rucaparib 200 mg QD
Serious: 1/6 (17%)
Deaths: 2/6
Rucaparib 300 mg BID
Serious: 0/5 (0%)
Deaths: 0/5
Rucaparib 300 mg QD
Serious: 1/16 (6%)
Deaths: 4/16
Rucaparib 400 mg BID
Serious: 0/2 (0%)
Deaths: 0/2

Serious adverse events (2 terms)

ReactionSystemRucaparib 200 mg BIDRucaparib 200 mg QDRucaparib 300 mg BIDRucaparib 300 mg QDRucaparib 400 mg BID
AnaphylaxisImmune system disorders
Pleuritic painRespiratory, thoracic and mediastinal disorders
Other adverse events (47 terms — click to expand)

ReactionSystemRucaparib 200 mg BIDRucaparib 200 mg QDRucaparib 300 mg BIDRucaparib 300 mg QDRucaparib 400 mg BID
Dermatitis radiationInjury, poisoning and procedural complications
FatigueGeneral disorders
PainGeneral disorders
Upper respiratory infectionInfections and infestations
LymphedemaVascular disorders
Peripheral sensory neuropathyNervous system disorders
Urinary tract infectionInfections and infestations
Adrenal insufficiencyEndocrine disorders
AguesiaGastrointestinal disorders
Ankle fractureInjury, poisoning and procedural complications
ArthralgiaMusculoskeletal and connective tissue disorders
Back painMusculoskeletal and connective tissue disorders
Breast atrophyReproductive system and breast disorders
CoughRespiratory, thoracic and mediastinal disorders
DepressionPsychiatric disorders
DiarrheaGastrointestinal disorders
DysphagiaGastrointestinal disorders
DyspneaRespiratory, thoracic and mediastinal disorders
Eye infectionInfections and infestations
FallInjury, poisoning and procedural complications
Fibrosis deep connective tissueMusculoskeletal and connective tissue disorders
Gastroesophageal reflux diseaseGastrointestinal disorders
HeadacheNervous system disorders
HemorrhoidsGastrointestinal disorders
HypothyroidismEndocrine disorders
Left chest wall tightnessMusculoskeletal and connective tissue disorders
Left rotator cuff tearMusculoskeletal and connective tissue disorders
Lymphocyte count decreasedInvestigations
Moist DesquamationInjury, poisoning and procedural complications
Neutrophil count decreasedInvestigations
Olfactory nerve disorderNervous system disorders
Pleuritic painRespiratory, thoracic and mediastinal disorders
PruritusSkin and subcutaneous tissue disorders
Radiation skin reactionInjury, poisoning and procedural complications
Rash maculo-papularSkin and subcutaneous tissue disorders
Receding gum lower center jawGastrointestinal disorders
Seborrheic dermatitis (scalp)Skin and subcutaneous tissue disorders
SeromaInjury, poisoning and procedural complications
ShinglesInfections and infestations
Skin indurationSkin and subcutaneous tissue disorders

Most-reported serious reactions: Anaphylaxis, Pleuritic pain.

Data from ClinicalTrials.gov NCT03542175 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Advances in synthetic lethality for cancer therapy: cellular mechanism and clinical translation.
    Topatana W, Juengpanich S, Li S, Cao J, et al · · 2020 · cited 128× · PMID 32883316 · DOI 10.1186/s13045-020-00956-5
  2. Development of synthetic lethality in cancer: molecular and cellular classification.
    Li S, Topatana W, Juengpanich S, Cao J, et al · · 2020 · cited 82× · PMID 33077733 · DOI 10.1038/s41392-020-00358-6
  3. Optimal Systemic Treatment for Early Triple-Negative Breast Cancer.
    Furlanetto J, Loibl S. · · 2020 · cited 37× · PMID 32774215 · DOI 10.1159/000508759
  4. Optimizing Radiation Therapy to Boost Systemic Immune Responses in Breast Cancer: A Critical Review for Breast Radiation Oncologists.
    Ho AY, Wright JL, Blitzblau RC, Mutter RW, et al · · 2020 · cited 32× · PMID 32417409 · DOI 10.1016/j.ijrobp.2020.05.011
  5. Early-stage Triple-negative Breast Cancer: Time to Optimize Personalized Strategies.
    Abuhadra N, Stecklein S, Sharma P, Moulder S. · · 2022 · cited 27× · PMID 35305094 · DOI 10.1093/oncolo/oyab003
  6. PARP Inhibitors in the Treatment of Early Breast Cancer: The Step Beyond?
    Gonçalves A, Bertucci A, Bertucci F. · · 2020 · cited 26× · PMID 32471249 · DOI 10.3390/cancers12061378
  7. DNA Repair: Translation to the Clinic.
    Minten EV, Yu DS. · · 2019 · cited 25× · PMID 30876709 · DOI 10.1016/j.clon.2019.02.007
  8. Harnessing DNA Repair Defects to Augment Immune-Based Therapies in Triple-Negative Breast Cancer.
    Clark CA, Yang ES. · · 2021 · cited 19× · PMID 34631532 · DOI 10.3389/fonc.2021.703802

Verify or expand the search:

Other trials of Rucaparib

Trials testing the same drug.

Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

Other Memorial Sloan Kettering Cancer Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03542175.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing