A Study of Ipatasertib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Hormone Receptor Positive and HER2 Negative Locally Advanced Unresectable or Metastatic Breast Cancer (IPATunity150)
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ClinicalTrials.gov Identifier: NCT04060862 |
Recruitment Status :
Terminated
(The decision to not open the Phase III portion was based on a strategic sponsor decision and not driven by any safety concerns.)
First Posted : August 19, 2019
Last Update Posted : April 3, 2024
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer | Drug: Ipatasertib Drug: Placebo Drug: Palbociclib Drug: Fulvestrant | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Phase Ib/III Study of Ipatasertib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Hormone Receptor Positive and HER2 Negative Locally Advanced Unresectable or Metastatic Breast Cancer |
Actual Study Start Date : | November 15, 2019 |
Actual Primary Completion Date : | August 29, 2023 |
Actual Study Completion Date : | August 29, 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: Phase 1b and Phase 3: Ipatasertib + Palbociclib +Fulvestrant |
Drug: Ipatasertib
Phase 1b: Ipatasertib, 300 mg starting dose administered orally once daily (PO QD) during an initial 5-7 day run-in period, then continued on Days 1-21 during the first cycle. Starting with Cycle 2, Day 1 ipatasertib will be taken orally once daily on Days 1-21 of each 28-day cycle. Phase 3: Ipatasertib, administered PO QD on Days 1-21 of each 28-day cycle at the dose confirmed in the Phase Ib portion.
Other Name: RO5532961, GDC-0068 Drug: Palbociclib Palbociclib, administered PO QD on Days 1-21 of each 28-day cycle. Drug: Fulvestrant Fulvestrant, 500 mg administered as two intramuscular injections of 250 mg each on Cycle 1 Days 1 and 15 and Day 1 of each subsequent 28-day cycle. |
Placebo Comparator: Phase 3: Placebo + Palbociclib + Fulvestrant |
Drug: Placebo
Phase 3: Matching placebo, administered PO QD on Days 1-21 of each 28-day cycle at the dose confirmed in the Phase Ib portion. Drug: Palbociclib Palbociclib, administered PO QD on Days 1-21 of each 28-day cycle. Drug: Fulvestrant Fulvestrant, 500 mg administered as two intramuscular injections of 250 mg each on Cycle 1 Days 1 and 15 and Day 1 of each subsequent 28-day cycle. |
- Progression-Free Survival (PFS) in Intent-to-Treat (ITT), as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) [ Time Frame: From randomization in Phase 3 until the first occurrence of disease progression or death from any cause, whichever occurs earlier, up to approximately 64 months ]
- Progression-Free Survival (PFS) in Patients with PIK3CA/AKT1/PTEN Altered Tumors, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) [ Time Frame: From randomization in Phase 3 until the first occurrence of disease progression or death from any cause, whichever occurs earlier, up to approximately 64 months ]
- Objective Response Rate (ORR) as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) [ Time Frame: From randomization in Phase 3 until the first occurrence of disease progression or death from any cause, whichever occurs earlier, up to approximately 64 months ]
- Duration of Objective Response (DOR) as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) [ Time Frame: From randomization in Phase 3 until the first occurrence of disease progression or death from any cause, whichever occurs earlier, up to approximately 64 months ]
- Clinical Benefit Rate (CBR) as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) [ Time Frame: From randomization in Phase 3 until the first occurrence of disease progression or death from any cause, whichever occurs earlier, up to approximately 64 months ]
- Overall Survival (OS) as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1 [ Time Frame: From randomization in Phase 3 until the first occurrence of disease progression or death from any cause, whichever occurs earlier, up to approximately 64 months ]
- Time to Deterioration (TTD) in Severity of Pain, according to the Brief Pain Inventory-Short Form (BPI-SF) [ Time Frame: From randomization in Phase 3 to the first documentation of a 2-point or more increase in pain scale from baseline, up to approximately 64 months ]
- TTD in presence and interference of pain according to the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ-C30) Pain Scale [ Time Frame: From randomization in Phase 3 to the first documentation of a 10-point or more increase from baseline, up to approx 64 months ]
- Time to deterioration (TTD) in physical functioning (PF) [ Time Frame: From randomization in Phase 3 to the first documentation of a 10-point or more decrease from baseline in the PF scale of the EORTC QLQ-C30, up to approx 64 months ]
- TTD in Role Functioning (RF) [ Time Frame: From randomization in Phase 3 to the first documentation of a 10-point or more decrease from baseline in the RF scale of the EORTC QLQ-C30, up to approx 64 months ]
- TTD in Global Health Status (GHS)/Quality of Life (QoL) [ Time Frame: From randomization in Phase 3 to the first documentation of a 10-point or more decrease from baseline in the GHS/HRQoL scale of the EORTC QLQ-C30, up to approx 64 months ]
- Number of Participants with Adverse Events [ Time Frame: From baseline to end of study, up to approximately 64 months ]
- Phase 1b: Plasma Concentration of Ipatasertib and its Metabolite, G-037720 and Palbociclib [ Time Frame: Ipatasertib & G-037720: predose, postdose at 0.5,1,2,3,4,6hr of Cycle(C) 1 (each cycle is 28 days), Day(D) 1, postdose at 0.5,1,2,3,4,6hr of C1D15, 2hr post-dose on C3D15; Palbociclib: predose on C1D15, C2D15 & C3D15 ]
- Phase 3: Plasma Concentration of Ipatasertib or its Placebo and its Metabolite, G-037720 [ Time Frame: 2-4 hrs after ipatasertib or its placebo on C1D1 (each cycle is 28 days), C1D15 and C2D15, Predose on C1D15, C2D15 ]
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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:
- HR+ HER2- adenocarcinoma of the breast that is locally advanced unresectable or metastatic
- For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs
- For men: agreement to remain abstinent or use contraceptive methods, and agreement to refrain from donating sperm
- Radiologic/objective relapse during adjuvant endocrine therapy or disease progression during the initial 12 months of 1L endocrine therapy in locally advanced unresectable or metastatic breast cancer
- At least one measurable lesion via Response Evaluation Criteria in Solid Tumors, Version 1.1
- Phase III only: Tumor specimen from the most recently collected, available tumor tissue
Exclusion Criteria:
- Pregnant or breastfeeding, or intending to become pregnant
- Prior treatment with fulvestrant or other selective estrogen receptor down-regulator
- Prior treatment with PI3K inhibitor, mTOR inhibitor or AKT inhibitor
- Phase III only: Prior treatment with CDK4/6 inhibitor for locally advanced unresectable or metastatic breast cancer
- Prior treatment with a cytotoxic chemotherapy regimen for metastatic breast cancer
- History of Type I or Type II diabetes mellitus requiring insulin
- History of or active inflammatory bowel disease or active bowel inflammation
- Lung disease: pneumonitis, interstitial lung disease, idiopathic pulmonary fibrosis, cystic fibrosis, Aspergillosis, active tuberculosis, or history of opportunistic infections
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): NCT04060862
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT04060862 |
Other Study ID Numbers: |
CO41012 2019-001072-11 ( EudraCT Number ) |
First Posted: | August 19, 2019 Key Record Dates |
Last Update Posted: | April 3, 2024 |
Last Verified: | April 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm). |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Fulvestrant Palbociclib Ipatasertib 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 |