Trial record 1 of 1 for:
FINER ipatasertib | Breast Cancer
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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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04650581 |
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Recruitment Status :
Active, not recruiting
First Posted : December 2, 2020
Last Update Posted : May 9, 2024
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Sponsor:
Canadian Cancer Trials Group
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Canadian Cancer Trials Group
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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 |
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 : | Interventional (Clinical Trial) |
| Actual Enrollment : | 250 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | 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 : | January 27, 2021 |
| Estimated Primary Completion Date : | June 30, 2024 |
| Estimated Study Completion Date : | December 31, 2026 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Breast cancer
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 :
- Progression-free survival (PFS) using RECIST 1.1 [ Time Frame: 5 years ]
Secondary Outcome Measures :
- 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 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
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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
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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
Locations
Show 39 study locations
Sponsors and Collaborators
Canadian Cancer Trials Group
Hoffmann-La Roche
Investigators
| Study Chair: | Stephen Chia | BCCA - Vancouver Cancer Centre, BC Canada |
| 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: | May 9, 2024 |
| Last Verified: | May 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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 Neoplasms Breast Diseases Ipatasertib Skin Diseases Fulvestrant Antineoplastic Agents, Hormonal Antineoplastic Agents |
Estrogen Receptor Antagonists Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |