A Study of Ipatasertib Plus Palbociclib and Fulvestrant in Hormone Receptor Positive and HER2 Negative Locally Advanced Unresectable or Metastatic Breast Cancer

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224945

Enrollment

370

Registered

2019-11-13

Start date

2019-12-05

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Interventions

investigational material(s) Generic name etc : Ipatasertib INN of investigational material : - Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational mate

Eligibility

Sex/Gender

All

Inclusion criteria

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 (RECIST v1.1). -Phase III only: Tumor specimen from the most recently collected, available tumor tissue..

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
efficacy RECIST v1.1	—

Secondary

Measure	Time frame
safety efficacy pharmacokinetics RECIST v1.1, BPI-SF, EORTC QLQ-C30, Observation	—

Countries

Asia except Japan, Europe, Japan, North America, Oceania, South America

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026