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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 : August 9, 2022
Hoffmann-La Roche
Information provided by (Responsible Party):
Canadian Cancer Trials Group

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).

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Ipatasertib Drug: Fulvestrant Other: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 1, 2020
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Fulvestrant

Arm Intervention/treatment
Experimental: Ipatasertib + Fulvestrant 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

Placebo Comparator: Placebo 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

Primary Outcome Measures :
  1. Progression-free survival (PFS) using RECIST 1.1 [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. 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 ]
  2. Investigator assessed PFS (per RECIST 1.1) in the PIK3CA/AKT1/PTEN non-altered cohort [ Time Frame: 5 years ]
  3. PFS as assessed by blinded central radiology review in all enrolled patients, PIK3CA/AKT1/PTEN altered and non-altered cohorts [ Time Frame: 5 years ]
  4. Response rate (RR) (per RECIST 1.1) [ Time Frame: 5 years ]
  5. Duration of Response (DoR) [ Time Frame: 5 years ]
  6. Clinical Benefit Rate (CBR); [ Time Frame: 5 years ]
  7. Overall survival (OS) [ Time Frame: 5 years ]
  8. Time to commencement of subsequent line of systemic therapy or death (TSST) [ Time Frame: 5 years ]
  9. Number of participants with treatment-related adverse events as assessed by CTCAE version 5.0 [ Time Frame: 5 years ]
  10. Quality of Life (QOL) as measured using EORTC QLQ-C30 questionnaire [ Time Frame: 5 years ]
  11. Adverse events as measured using NCI PRO-CTCAE questionnaire [ Time Frame: 5 years ]
  12. 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 ]
  13. Economic Evaluation of health utilities measured using EQ-5D-5L [ Time Frame: 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04650581

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Contact: Wendy Parulekar 613-533-6430 wparulekar@ctg.queensu.ca

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Sponsors and Collaborators
Canadian Cancer Trials Group
Hoffmann-La Roche
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Study Chair: Stephen Chia BCCA - Vancouver Cancer Centre, BC Canada
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Responsible Party: Canadian Cancer Trials Group
ClinicalTrials.gov Identifier: NCT04650581    
Other Study ID Numbers: MA40
2101 ( Other Identifier: BCT )
M041883 ( Other Identifier: Hoffmann-LaRoche Ltd. )
First Posted: December 2, 2020    Key Record Dates
Last Update Posted: August 9, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs