RECRUITINGPhase 2INTERVENTIONAL
To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer
A Phase II, Randomized, Open-Label Study Evaluating Two Inavolisib Dose Levels in Combination With Fulvestrant in Participants With PIK3CA-Mutated, HR-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
About This Trial
The purpose of this study is to evaluate the efficacy and safety of inavolisib in combination with fulvestrant compared with inavolisib in combination with fulvestrant in participants with PIK3CA-mutated, HR-positive, HER2-negative locally advanced or metastatic breast cancer (LA/mBC) in the post-cyclin-dependent kinase inhibitor (CDKi) setting.
Who May Be Eligible (Plain English)
Who May Qualify:
- Documented ER +/ HER2- tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines
- Disease progression after or during treatment with a combination of CDK4/6i and endocrine therapy: \<= 1 prior lines of systemic therapy in the locally advanced (recurrent or progressed) or metastatic setting
- Measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
- Participants for whom endocrine-based therapy is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study, as per national or local treatment guidelines
- Confirmation of biomarker eligibility: presence of \>= 1 study-eligible PIK3CA mutation
- Life expectancy of \> 6 months
- Ability, in the investigator's judgment, and willingness to comply with all study -related procedures, including completion of patient-reported outcomes
Who Should NOT Join This Trial:
- Metaplastic breast cancer
- Prior treatment with chemotherapy in the recurrent locally advanced/metastatic setting
- Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
- Prior treatment with PI3K/Akt/mTOR inhibitors in the recurrent locally advanced/metastatic setting
- Requirement for daily supplemental oxygen
- Symptomatic active lung disease, including pneumonitis
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* Documented ER +/ HER2- tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines
* Disease progression after or during treatment with a combination of CDK4/6i and endocrine therapy: \<= 1 prior lines of systemic therapy in the locally advanced (recurrent or progressed) or metastatic setting
* Measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
* Participants for whom endocrine-based therapy is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study, as per national or local treatment guidelines
* Confirmation of biomarker eligibility: presence of \>= 1 study-eligible PIK3CA mutation
* Life expectancy of \> 6 months
* Ability, in the investigator's judgment, and willingness to comply with all study -related procedures, including completion of patient-reported outcomes
Exclusion Criteria:
* Metaplastic breast cancer
* Prior treatment with chemotherapy in the recurrent locally advanced/metastatic setting
* Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
* Prior treatment with PI3K/Akt/mTOR inhibitors in the recurrent locally advanced/metastatic setting
* Requirement for daily supplemental oxygen
* Symptomatic active lung disease, including pneumonitis
Treatments Being Tested
DRUG
Inavolisib
Participants will receive Inavolisib as per the schedule given in the protocol.
DRUG
Fulvestrant
Participants will receive Fulvestrant as per the schedule given in the protocol.
Locations (14)
Los Angeles Cancer Network
Los Angeles, California, United States
Astera Cancer Care East Brunswick
East Brunswick, New Jersey, United States
Cliniques Universitaires St-Luc
Brussels, Belgium
UZ Leuven Gasthuisberg
Leuven, Belgium
Vall d?Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, Spain
Hospital Universitario San Cecilio
Granada, Spain
Hospital Universitario 12 De Octubre
Madrid, Spain
Hospital Clinico Universitario de Valencia
Valencia, Spain
Bagcilar Medipol Mega Universitesi Hastanesi
Bağcılar, Istanbul, Turkey (Türkiye)
Adana Baskent University Hospital
Adana, Turkey (Türkiye)
Memorial Ankara Hastanesi
Ankara, Turkey (Türkiye)
Medical Park Seyhan Hospital
Seyhan, Turkey (Türkiye)
Princess Alexandra Hospital
Harlow, United Kingdom
Mount Vernon Cancer Centre
Northwood, Middlesex, United Kingdom