PARP Inhibition During Pre-surgical Window in Breast/Ovary Cancer

This is an interventional basic science trial for Ovarian Cancer Read More

Inclusion Criteria:

• All patients must have cytology/ biopsy proven diagnosis of a mullerian carcinoma, high clinical index of suspicion for ovarian cancer OR triple negative, BRCA mutated breast cancer.
• Patients may not have received prior treatment for breast or ovarian cancer.
• All patients must be of at least 18 years of age.
• ECOG Performance status must be 0,1 or 2.
• Patients must not have received a prior PARP inhibitor
• Adequate organ and marrow function as defined below:
• absolute neutrophil count >/= 1500/mcL
• Platelets > /= 100,000 /mcl
• Hemoglobin >/= 8 g/dl
• Total bilirubin </= 1.5 x the institutional ULN
• AST, ALT </= 3 x the institutional ULN
• Creatinine </= the institutional ULN
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

• A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:

  • Has not undergone a hysterectomy or bilateral oophorectomy; or
  • Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
• Patients must be able to swallow and retain oral medications.
• Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

• Chemotherapy, radiotherapy, or other cancer therapy within 4 weeks prior to starting study treatment. Subjects must have recovered from prior treatment-related to toxicities to grade 1 or baseline (excluding alopecia and clinically stable toxicities requiring ongoing medical management, such as hypothyroidism from prior immune checkpoint inhibitor treatment).
• Subjects may not be receiving any other investigational agents for the treatment of the cancer under study.
• Brain metastases
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to Lynparza or other agents used in study.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements.
• Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.