Palbociclib With Fulvestrant for Metastatic Breast Cancer After Treatment With Palbociclib and an Aromatase Inhibitor

NCT02738866 | Active Not Recruiting Phase 2

• 2 other identifiers: J15212IRB00086616
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

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.

Conditions

Metastatic Breast Cancer

Keywords

breast cancer; Metastatic Breast Cancer; palbociclib; fulvestrant

Outcome Measures

Primary Outcomes (2)

• Progression-free survival

  To estimate progression-free survival (PFS) of palbociclib and fulvestrant in women and men with ER/PR-positive, HER2-negative MBC who progressed on a palbociclib and an AI

  6 months

• Prevalence of ESR1 and PI3K mutations

  To determine the prevalence of ESR1 and PI3K mutations in tissue and in ptDNA in women and men with ER/PR-positive, HER2-negative MBC who progressed on a palbociclib and an AI

  6 months

Study Arms (1)

Palbociclib and Fulvestrant

EXPERIMENTAL

Participants will receive fulvestrant with palbociclib until disease progression or unacceptable toxicity.

Drug: Palbociclib; Drug: Fulvestrant

Interventions

Fulvestrant DRUG

Fulvestrant 500 mg should be administered intramuscularly into the buttocks slowly (1-2 minutes per injection) as two 5 mL injections, one in each buttock, on days 1, 15, and 29 (i.e., Cycle 2 Day 1) and once monthly thereafter (i.e., day 1 of each cycle).

Also known as: Faslodex

Palbociclib and Fulvestrant

Palbociclib DRUG

Palbociclib will be given orally, continued at the same dose as was received previously; the maximum starting dose will be per the approved label, a dose of 125 mg once daily. Palbociclib will be taken days 1-21, then seven days off treatment to complete one 28 day cycle.

Also known as: Ibrance

Palbociclib and Fulvestrant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Pfizer: collaborator

Study Sites (5)

Kimmel Cancer Center at Johns Hopkins at Sibley Memorial Hospital

Washington D.C., District of Columbia, 20016, United States

Location

Anne Arundel Health System Research Institute, Inc.

Annapolis, Maryland, 21401, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

Allegheny Health Network (AHN) - Allegheny General Hospital ONLY

Pittsburgh, Pennsylvania, 15212, United States

Location

Reading Hospital - McGlinn Cancer Institute

West Reading, Pennsylvania, 19611, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

palbociclib; Fulvestrant

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Vered Stearns, M.D.

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  STUDY CHAIR

• Jessica Tao, MD

  SKCCC Johns Hopkins Medical Institution

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2016
• First Posted: April 14, 2016
• Study Start: October 25, 2016
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)