Palbociclib With Fulvestrant for Metastatic Breast Cancer After Treatment With Palbociclib and an Aromatase Inhibitor
NCT02738866
ABOUT THIS STUDY
FOR MORE INFORMATION
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410-614-1361
- Women may be premenopausal or postmenopausal
- Metastatic or locally advanced breast cancer, not amenable to surgery or radiation with curative intent
- ER-positive and/or PR-positive, HER2-negative tumor
- Prior treatment: progressed on and following at least 6 months of combined treatment with palbociclib and AI therapy; up to one (1) prior line of chemotherapy for advanced disease is allowed in addition to any number of prior lines of endocrine therapy; no prior treatment with fulvestrant, everolimus, or any agent whose mechanism of action is to inhibit the PI3K-mTOR pathway in the metastatic setting
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Evaluable or measurable disease
- Disease that is amenable to biopsy
- Adequate hematologic and renal function
- History of central nervous system metastasis is allowed if treated and stable
- Prior radiation therapy is allowed if recovered from toxicity and disease evaluable for response outside of the radiation fields or evidence of post-radiation progression of previously irradiated sites of disease
- Ability to understand and willingness to sign a written informed consent document
- Women who are pregnant or breast-feeding
- Concurrent use of inhibitors or inducers of CYP3A4, or medications which prolong the
QTc interval
- Major surgery, chemotherapy, radiotherapy, or other anti-cancer therapy within 2 weeks
before registration; prior radiotherapy to ≥25% of bone marrow are not eligible
independent of when it was received
- Any other malignancy within 3 years prior to registration, except for adequately
treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix
- Any severe cardiac event within 6 months of registration
- Prior hematopoietic stem cell or bone marrow transplantation
- Known abnormalities in coagulation such as bleeding diathesis, or treatment with
anticoagulants precluding intramuscular injections of fulvestrant or goserelin (if
applicable)
- Known or possible hypersensitivity to palbociclib, fulvestrant, goserelin (if
applicable) or to any of their excipients
- Known human immunodeficiency virus infection
- Other severe acute or chronic medical or psychiatric condition, including recent or
active suicidal ideation or behavior, or laboratory abnormality that may increase the
risk associated with study participation or investigational product administration or
may interfere with the interpretation of study results and, in the judgment of the
investigator, would make the patient inappropriate for entry into this study
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Descriptive Information | |||||||||
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Brief Title ICMJE | Palbociclib With Fulvestrant for Metastatic Breast Cancer After Treatment With Palbociclib and an Aromatase Inhibitor | ||||||||
Official Title ICMJE | Phase II Trial of Palbociclib With Fulvestrant in Individuals With Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer Who Have Progressed on Treatment With Palbociclib and an Aromatase Inhibitor | ||||||||
Brief Summary | This study is being done to look at the role of continuing palbociclib treatment in combination with another type of hormonal therapy (fulvestrant) after disease progression of palbociclib in combination with an aromatase inhibitor. | ||||||||
Detailed Description | In this phase II trial, the primary objective is to determine the progression-free survival (PFS) of the cyclin dependent kinase 4/6 inhibitor (CDK4/6i) palbociclib with fulvestrant in women and men with estrogen or progesterone receptor (ER/PR) positive, HER2-negative metastatic breast cancer (MBC) who progressed on treatment with palbociclib and an aromatase inhibitor (AI). The study will also determine the prevalence rate of estrogen receptor ? (ESR1) and phosphatidylinositol-3-kinase (PI3K) mutations in the study population. The secondary objectives include evaluating the progression-free survival (PFS) in participants with and without ESR1 mutations, and PI3K mutations through analysis of tumor biopsies and circulating plasma tumor DNA (ptDNA) samples. The study will also describe other alterations in genes and gene products relevant to the cell cycle, drug targets, tumor sensitivity and resistance, and identify novel protein kinases activated in biopsies from participants with hormone refractory MBC who progressed on prior palbociclib and AI. The data will be correlated with tumor subtypes, expression profiles, and candidate phosphoprotein expression with PFS in the study population. | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 2 | ||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||||||
Condition ICMJE | Metastatic Breast Cancer | ||||||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Palbociclib and Fulvestrant
Participants will receive fulvestrant with palbociclib until disease progression or unacceptable toxicity. Interventions:
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||||
Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE | 100 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | January 2023 | ||||||||
Estimated Primary Completion Date | January 2023 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT02738866 | ||||||||
Other Study ID Numbers ICMJE | J15212 IRB00086616 ( Other Identifier: JHMIRB ) | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product | Not Provided | ||||||||
IPD Sharing Statement ICMJE |
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Responsible Party | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | ||||||||
Study Sponsor ICMJE | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | ||||||||
Collaborators ICMJE | Pfizer | ||||||||
Investigators ICMJE |
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PRS Account | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | ||||||||
Verification Date | January 2021 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |