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



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:11/16/2018
Start Date:May 23, 2018
End Date:May 2020
Contact:Atif Khan, MD
Email:khana7@mskcc.org
Phone:848-225-6334

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A Phase I Study of Rucaparib Administered Concurrently With Postoperative Radiotherapy in Patients With Triple Negative Breast Cancer With an Incomplete Pathologic Response Following Neoadjuvant Chemotherapy

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.


Inclusion Criteria:

- 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).

- Definitive surgical treatment with breast-conserving surgery or mastectomy and
axillary lymph node evaluation.

- Residual disease in the breast or lymph nodes at the time of definitive surgical
treatment.

- At least 6-month life expectancy, ECOG Performance status < 2.

- 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/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

1. If calculated creatinine clearance is < 45mL/min, a 24-hour urine collection
for creatinine clearance may be performed

2. Subjects with documented Gilbert's disease may have bilirubin up to 2.5
mg/dL

- Negative serum pregnancy test within 14 days prior to study treatment if a woman has
child-bearing potential. Subjects of child bearing potential are those who have not
been surgically sterilized or have not been free from menses for > 1 year.

- Ability to swallow and retain oral medications.

- Written informed consent obtained from subject and ability for subject to comply with
the requirements of the study.

- Female subjects of childbearing potential should be willing to use 2 methods of birth
control or be surgically sterile, or abstain from heterosexual activity for the
duration of study participation. Should a woman become pregnant while participating on
study, she should inform the treating physician immediately.

Exclusion Criteria:

- Gross residual tumor or positive margins after surgery that is 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 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.

- 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.
We found this trial at
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Rockville Centre, New York 11570
Phone: 848-225-6334
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Basking Ridge, New Jersey 07920
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Commack, New York 11725
Phone: 848-225-6334
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500 Westchester Avenue
Harrison, New York 10604
Phone: 848-225-6334
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480 Red Hill Road
Middletown, New Jersey 07748
Phone: 848-225-6334
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225 Summit Avenue
Montvale, New Jersey 07645
Phone: 848-225-6334
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1275 York Ave
New York, New York 10021
(212) 639-2000
Phone: 848-225-6334
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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