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

NCT02738866

Last updated date
Study Location
Kimmel Cancer Center at Johns Hopkins at Sibley Memorial Hospital
Washington, District of Columbia, 20016, United States
Contact
410-614-1361

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Metastatic Breast Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Advanced Information
Descriptive Information
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
  • Drug: Palbociclib
    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.
    Other Name: Ibrance
  • Drug: Fulvestrant
    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).
    Other Name: Faslodex
Study Arms  ICMJE Experimental: Palbociclib and Fulvestrant
Participants will receive fulvestrant with palbociclib until disease progression or unacceptable toxicity.
Interventions:
  • Drug: Palbociclib
  • Drug: Fulvestrant
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
 (submitted: April 11, 2016)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2021
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hopkins Breast Trials410-614-1361[email protected]
Contact: Kimmel Cancer Center Clinical Research Office410-955-8866[email protected]
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
Plan to Share IPD:No
Plan Description:There is no plan to make individual participant data available.
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
Study Chair:Vered Stearns, M.D.Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
PRS Account Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP