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

  • STATUS
    Recruiting
  • End date
    Jul 23, 2024
  • participants needed
    20
  • sponsor
    University of Texas Southwestern Medical Center
Updated on 29 March 2021
carcinoma
breast cancer
neutrophil count
cancer chemotherapy
parp inhibitor
tumor debulking
cytoreduction
cancer of the ovary

Summary

Study involves surgery for cytoreduction or laparoscopy to determine if you are a candidate for tumor debulking or a tissue biopsy. Following this surgery you will receive chemotherapy. This study will administer 7 days of treatment with a targeted therapy called Lynparza. Lynparza and/or other PARP inhibitors have been FDA approved for the treatment of ovarian and breast cancer. Tissue biopsy will be done before a 7 day course of Lynparza in order to correlate molecular changes to response to treatment. Participation in this trial will require an additional tumor biopsy which will occur either before or after treatment of Lynparza.

Details
Condition Ovarian disorder, Breast Cancer, Ovarian Cancer, Ovarian Function, Breast Cancer Diagnosis, Recurrent Ovarian Cancer, breast carcinoma, ovarian carcinomas, cancer, ovarian, cancer ovarian, cancer of the ovary, cancer, breast, ovarian tumors
Treatment Lynparza
Clinical Study IdentifierNCT04041128
SponsorUniversity of Texas Southwestern Medical Center
Last Modified on29 March 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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