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Fulvestrant and Ipatasertib for Advanced HER-2 Negative and Estrogen Receptor Positive (ER+) Breast Cancer Following Progression on First Line CDK 4/6 Inhibitor and Aromatase Inhibitor (FINER)

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ClinicalTrials.gov Identifier: NCT04650581
Recruitment Status : Recruiting
First Posted : December 2, 2020
Last Update Posted : September 14, 2021
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Canadian Cancer Trials Group

Tracking Information
First Submitted Date  ICMJE November 24, 2020
First Posted Date  ICMJE December 2, 2020
Last Update Posted Date September 14, 2021
Actual Study Start Date  ICMJE December 1, 2020
Estimated Primary Completion Date June 30, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2020)
Progression-free survival (PFS) using RECIST 1.1 [ Time Frame: 5 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2020)
  • To compare the two treatment arms with respect to investigator assessed PFS (per RECIST 1.1) in the PIK3CA/AKT1/PTEN altered cohort [ Time Frame: 5 years ]
  • Investigator assessed PFS (per RECIST 1.1) in the PIK3CA/AKT1/PTEN non-altered cohort [ Time Frame: 5 years ]
  • PFS as assessed by blinded central radiology review in all enrolled patients, PIK3CA/AKT1/PTEN altered and non-altered cohorts [ Time Frame: 5 years ]
  • Response rate (RR) (per RECIST 1.1) [ Time Frame: 5 years ]
  • Duration of Response (DoR) [ Time Frame: 5 years ]
  • Clinical Benefit Rate (CBR); [ Time Frame: 5 years ]
  • Overall survival (OS) [ Time Frame: 5 years ]
  • Time to commencement of subsequent line of systemic therapy or death (TSST) [ Time Frame: 5 years ]
  • Number of participants with treatment-related adverse events as assessed by CTCAE version 5.0 [ Time Frame: 5 years ]
  • Quality of Life (QOL) as measured using EORTC QLQ-C30 questionnaire [ Time Frame: 5 years ]
  • Adverse events as measured using NCI PRO-CTCAE questionnaire [ Time Frame: 5 years ]
  • Economic Evaluation of healthcare utilization using average cost per study subject by treatment arm to estimate an overall mean cost per study arm. [ Time Frame: 5 years ]
  • Economic Evaluation of health utilities measured using EQ-5D-5L [ Time Frame: 5 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fulvestrant and Ipatasertib for Advanced HER-2 Negative and Estrogen Receptor Positive (ER+) Breast Cancer Following Progression on First Line CDK 4/6 Inhibitor and Aromatase Inhibitor
Official Title  ICMJE A Double-Blind Placebo-Controlled Randomized Phase III Trial of Fulvestrant and Ipatasertib as Treatment for Advanced HER-2 Negative and Estrogen Receptor Positive (ER+) Breast Cancer Following Progression on First Line CDK 4/6 Inhibitor and Aromatase Inhibitor
Brief Summary The purpose of this study is to find out whether a new drug, Ipatasertib, can slow the growth of advanced breast cancer when added to standard therapy (Fulvestrant).
Detailed Description Patients enrolled in this study will receive either Ipatasertib plus Fulvestrant or placebo (a substance that looks like the study drug but does not have any active or medicinal ingredient) plus Fulvestant. The study will provide information about the ability of Ipatasertib plus Fulvestrant to control the cancer, the side effects and safety of the treatment, how patients feel while taking the treatment and associated costs.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: Ipatasertib
    400 mg PO QD days 1-21 every 28 days
  • Drug: Fulvestrant
    500 mg IM cycle 1 days 1 and 15 followed by 500 mg IM day 1 q 28 days subsequent cycles
  • Other: Placebo
    PO QD days 1-21 every 28 days
Study Arms  ICMJE
  • Experimental: Ipatasertib + Fulvestrant
    Interventions:
    • Drug: Ipatasertib
    • Drug: Fulvestrant
  • Placebo Comparator: Placebo
    Interventions:
    • Drug: Fulvestrant
    • Other: Placebo
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: December 1, 2020)
250
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2026
Estimated Primary Completion Date June 30, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically and/or cytologically confirmed ER positive, HER-2 negative breast cancer
  • Female patients must be post-menopausal; female patients who are pre-menopausal must have ovarian suppression using LHRH agonist while on study
  • Clinical and/or radiographic progression during treatment with or within 28 days after discontinuation of first line of treatment with a CDK 4/6 inhibitor and an aromatase inhibitor (AI) for advanced/metastatic disease
  • Evidence of clinically and/or radiologically documented disease
  • ≥ 18 years of age
  • ECOG performance status of 0 or 1
  • No concurrent anti-cancer therapy and must satisfy the following criteria for previous therapy

    • Must not have received more than one prior line of treatment with a CDK 4/6 inhibitor and an AI in the advanced disease setting.
    • Treatment with CDK 4/6 inhibitor and AI must have been the most recent treatment prior to registration for this study
  • Adequate hematology and organ function, in the absence of growth factors

    • Absolute neutrophils > 1.5 x 10^9/L
    • Platelets ≥ 100 x 10^9/L
    • Hemoglobin > 90 g/L
    • Total Bilirubin ≤ 1.5 x ULN (upper limit of normal) or ≤ 3 x ULN if confirmed Gilbert's Syndrome
    • ALT and AST ≤ 2.5 x ULN (or ≤ 5.0 x ULN if liver or bone metastasis)
    • Alkaline phosphatase ≤ 2.0 x ULN (or ≤ 5.0 x ULN if liver metastases, ≤ 7.0 x ULN if bone metastasis)
    • Fasting glucose ≤ 8.3 mmol/L
    • HbA1c ≤ 7.5%
    • Serum albumin ≥ 30 g/L
    • INR ≤ 1.2
    • Serum Creatinine or Creatinine clearance ≤ 1.5 x ULN or ≥ 50 mL/min; measured directly by 24-hour urine sampling or as calculated by Crockcroft and Gault equation

Exclusion Criteria:

  • Untreated or symptomatic CNS metastases, radiation treatment for CNS metastases within 28 days
  • Active inflammatory bowel disease, bowel inflammation, inability to swallow oral medication or GI condition that alters oral absorption
  • Prior treatment with fulvestrant, selective estrogen receptor degraders (SERDs) or known inhibitors of the PI3K pathway including PI3K inhibitors, AKT inhibitors, or mTOR inhibitors
  • Mean QT interval corrected for heart rate (QTc) ≥ 480 msec by ECG or history of familial long QT syndrome
  • Active or uncontrolled infections or serious illnesses or medical conditions
  • Clinically significant liver diseases
  • History of lung disease or history of opportunistic infections
  • Type 1 or Type 2 diabetes mellitus requiring insulin
  • Grade ≥ 2 uncontrolled hypercholesterolemia or hypertriglyceridemia
  • Known abnormalities in coagulation
  • History of hypersensitivity to the study drugs or components
  • Pregnant or lactating women
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: Wendy Parulekar 613-533-6430 wparulekar@ctg.queensu.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04650581
Other Study ID Numbers  ICMJE MA40
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Canadian Cancer Trials Group
Study Sponsor  ICMJE Canadian Cancer Trials Group
Collaborators  ICMJE Hoffmann-La Roche
Investigators  ICMJE
Study Chair: Stephen Chia BCCA - Vancouver Cancer Centre, BC Canada
PRS Account Canadian Cancer Trials Group
Verification Date January 2021

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