A Phase I Study of Niraparib Administered Concurrently With Postoperative RT in Triple Negative Breast Cancer Patients

Running, not enrolling · Phase 1

Conditions studied: Triple Negative Breast Cancer, Residual Disease

In brief

This research study involves Niraparib as a possible treatment for triple negative breast cancer.

Key facts

Study ID

NCT03945721

Run by

Massachusetts General Hospital

People needed

21

Starts

2019-07-11

Expected to finish

2028-12-31

Last updated by the study team

2026-06-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or Females, ≥ 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).
• Definitive surgical treatment with breast-conserving surgery or mastectomy and axillary lymph node evaluation.
• Plans for receipt of postoperative radiation therapy to the breast/chest wall +/- regional nodes
• Residual invasive disease after NAC (any size), or at least 1.0 cm in patients who do not receive NAC and undergo surgery first.
• ECOG Performance status ≤ 1.
• Willingness to discontinue any cytotoxic chemotherapeutic agents, immunotherapy 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/mm3
• Platelet Count ≥100,000/mm3
• Hemoglobin ≥9.0 g/dL
• Renal Function
• Creatinine Serum ≤ 1.5 mg/dL or
• Creatinine Clearance ≥ 45 mL/mina
• Hepatic Function
• Bilirubin ≤ 1.5 mg/dL
• Aspartate Aminotransferase (AST) ≤ 2.5 x ULNb
• Alanine Aminotransferase (ALT) ≤ 2.5 x ULN
• ULN = upper normal limit of institution's normal range
• If calculated creatinine clearance is < 45mL/min, a 24-hour urine collection for creatinine clearance may be performed
• Subjects with documented Gilbert's disease may have bilirubin up to 2.5 mg/dL
• Female participants have a negative urine or serum pregnancy test within 7 days prior to study treatment if a woman has child-bearing potential, and agrees to abstain from activities that could result in pregnancy from screening through 180 days after the last dose of study treatment, or is of non-childbearing potential.
• Non-childbearing potential is defined as follows (by other than medical reasons):
• -≥45 years of age and has not had menses for >1 year

You may not qualify if…

• Gross residual tumor or positive margins after surgery that is un-excised (excluding positive margins at the chest wall or skin where no additional breast tissue can be removed).
• pT1aN0 or pT1bN0 (primary tumor size <1.0 cm) triple negative breast cancer patients who do undergo neoadjuvant chemotherapy and receive surgery followed by +/- adjuvant chemotherapy.
• Receipt of PARP inhibitor at any time prior to study enrollment.
• 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 that was completed ≥ 1 week prior to Day 1 of protocol therapy, or if prior RT encompassed >20% of the bone marrow it was completed ≥ 2 weeks prior to Day 1 of protocol therapy, is permitted).
• Major surgery ≤ 3 weeks prior to initiating protocol therapy and participant must have recovered from any surgical effects.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to niraparib, or its components or excipients.
• 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.
• 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.
• Treatment with investigational therapy within ≤ 4 weeks, or within a time interval less than at least five half-lives of the investigational agent, whichever is shorter, prior to initiating protocol therapy. Patients may not be simultaneously enrolled in any interventional clinical trial.
• Unresolved toxicity from other agents. Patients with unresolved CTCAE v5 Grade 2 or greater toxicity, with the exception of alopecia and anemia, from prior administration of another investigational drug and/or anti-cancer treatment are not eligible.
• Known grade 3 or 4 anemia, neutropenia, or thrombocytopenia that persisted > 4 weeks and was related to the most recent chemotherapy treatment.
• Participant must not have received a transfusion (platelets or red blood cells) ≤ 4 weeks prior to initiating protocol therapy.
• Participant must not have received colony-stimulating factors (e.g. granulocyte colony-stimulating factor, granulocyte macrophage colony-stimulating factor, or recombinant erythropoietin) within 4 weeks prior to initiating protocol therapy.
• Prior malignancy within 5 years of study enrollment.
• Scleroderma and systemic lupus erythematosis.
• Known p53 germline mutations.
• Known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
• Known symptomatic brain or leptomeningeal metastases.
• Dose Cohort 2 only:
• Actual body weight < 77kg OR
• Platelet count < 150,000 µL

Where it is running

• Massachusetts General Hospital Cancer Center — Boston, Massachusetts, United States
• Dana Farber Cancer Institute/Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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