HOPE: Olaparib, Palbociclib and Fulvestrant in Patients With BRCA Mutation-associated, HR+, HER2-metastatic Breast Cancer

  • STATUS
    Recruiting
  • End date
    Apr 29, 2024
  • participants needed
    54
  • sponsor
    Abramson Cancer Center of the University of Pennsylvania
Updated on 4 October 2022

Summary

The main purpose of this research study is to learn whether the investigational combination of olaparib, palbociclib, and fulvestrant is safe in patients with estrogen receptor-positive breast cancer and BRCA1 or BRCA2 mutations.

Details
Condition Metastatic Breast Cancer, Locally Advanced Breast Cancer, BRCA2 Mutation, BRCA1 Mutation, Stage IV Breast Cancer, Advanced Breast Cancer
Treatment olaparib, fulvestrant, Palbociclib
Clinical Study IdentifierNCT03685331
SponsorAbramson Cancer Center of the University of Pennsylvania
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Females/males age 18
Germline or somatic deleterious or suspected deleterious mutation in BRCA1 or BRCA2
Metastatic or locally advanced unresectable breast cancer that is ER and/or PR positive (>1%) and HER2 nonamplified
Prior treatment with 0-2 prior lines of chemotherapy for metastatic breast cancer
Regarding prior platinum-based chemotherapy
Patients who received prior platinum-based chemotherapy in the adjuvant or neoadjuvant setting for breast cancer are eligible if treatment was completed at least 12 months prior to diagnosis of metastatic disease
Patients who received platinum for advanced breast cancer are eligible to enter the study provided there was no evidence of disease progression during the platinum chemotherapy
Patients who received prior platinum-based as a potentially curative treatment for a prior non-breast cancer (e.g., ovarian cancer) with no evidence of disease for 5 years or greater prior to study entry are permitted
Deemed a candidate for endocrine therapy (any prior endocrine therapy is permitted; no prior endocrine therapy is also permitted)
Adequate organ and bone marrow function
ECOG performance status 0-1
Life expectancy 16 weeks
At least one measurable disease or disease that can be assessed by CT or MRI
Postmenopausal as defined below. Women who are on pharmacologic ovarian suppression must have two negative urine or serum pregnancy tests: one during screening (within 28 days prior to study treatment) and one within 7 days prior to commencing treatment
Willing to comply with study requirements and procedures including use of appropriate contraception, willingness to discontinue herbal preparations / medications, and study biopsy if archival tissue is not available
Postmenopausal is defined as one of the below
Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments
Follicle stimulating hormone (FSH) levels in the post-menopausal range for women under 50
radiation-induced oophorectomy with last menses >1 year ago
chemotherapy-induced menopause with >1 year interval since last menses
bilateral oophorectomy or hysterectomy
on luteinizing hormone-releasing hormone (LHRH) agonists according to current clinical practice standards as pharmacologic ovarian suppression
Female patients of childbearing potential (not post-menopausal as defined above) must agree to the use of two highly effective forms of contraception in combination throughout the period of taking study treatment and for 1 month after last dose of study drug(s) to prevent pregnancy
Male patients and their sexual partners of childbearing potential must agree to the use of two highly effective forms of contraception in combination throughout the period of taking study treatment and for 3 months after last dose of study drug(s) to prevent pregnancy in a partner

Exclusion Criteria

Involvement in study planning or conduct
Participation in another clinical study with an investigational product during the last 3 weeks
Other malignancy within the last 5 years with exceptions listed in the protocol
Concomitant strong or moderate CYP3A inhibitors/ inducers
Persistent toxicity of prior cancer therapy that is grade 2 except for alopecia or neuropathy
MDS or features suggestive of MDS/AML
Symptomatic uncontrolled brain metastases
Regarding prior olaparib or palbociclib
Patients considered to be at poor medical risk
Phase II: Patients who previously progressed on olaparib or palbociclib for metastatic breast cancer treatment are excluded
QTc >470 msec on 2 or more time points or a family history of long QT syndrome
Unable to swallow or absorb oral medication
Systemic chemotherapy or radiotherapy (except palliative) within 3 weeks of start of study treatment
Immunocompromised patients
Pregnant or breast-feeding
Major surgery within 2 weeks of start of study treatment
Hypersensitivity to olaparib, palbociclib, fulvestrant, or any excipients of these products
Prior bone marrow transplant
Whole blood transfusions 120 days prior to signing consent
Known active hepatitis
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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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