Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-positive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor.
Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-positive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor.

NCT05038735

Active Not RecruitingPhase 3

Sponsor: Novartis Pharmaceuticals

Conditions: Breast Cancer

Interventions: Alpelisib, Fulvestrant, Alpelisib-matching placebo

Countries: Belgium, Bulgaria, Canada, Czechia, Denmark, Finland, France, Germany

The purpose of this study is to complement Study CBYL719C2301 (SOLAR-1) and obtain more comprehensive data on the efficacy and safety of alpelisib (BYL719) in combination with fulvestrant compared with placebo plus fulvestrant in men or postmenopausal women with HR-positive, HER2-negative advanced breast cancer with a PIK3CA mutation who progressed or relapsed on or after treatment with an AI plus a CDK4/6 inhibitor.

Eligibility overview

Sex: ALL

Age: 18 Years to 100 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Key Inclusion Criteria:

* Participant is an adult ≥ 18 years old at the time of informed consent and has signed informed consent before any trial related activities and according to local guidelines.
* Participant has a histologically and/or cytologically confirmed diagnosis of ER+ and/or PgR+ breast cancer by local laboratory.
* Participant has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (Fluorescent in situ hybridization (FISH), Chromogenic in situ hybridization (CISH), or Silver-enhanced in situ hybridization (SISH)) test is required by local laboratory testing.
* Participant has at least one measurable lesion as per RECIST v1.1 criteria as assessed by Investigator (a lesion at a previously irradiated site may only be counted as a target lesion if there is clear sign of progression since the irradiation).
* Participant has recurrence or progression of disease during or after combined AI (i.e. letrozole, anastrozole, exemestane) and CDK4/6 inhibitor therapy. The combined AI and CDK4/6 inhibitor therapy does not need to be the latest treatment regimen (including adjuvant setting).
* Participant has received ≤ 2 prior lines of systemic therapies overall in the metastatic setting, of which a maximum of 1 line of prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy) is permitted.
* The presence of PIK3CA mutation(s) determined in tumor tissue prior to enrollment either by a Novartis designated laboratory or in tumor tissue or plasma ctDNA by a local laboratory using a Food and Drug Administration (FDA)-approved PIK3CA Companion Diagnostics (CDx) test for alpelisib or the CE-IVD QIAGEN Therascreen® PIK3CA RGQ PCR test.
* If female, then the participant must be in postmenopausal status.

Key Exclusion Criteria:

* Participant with symptomatic visceral disease or any disease burden that makes the participant ineligible for endocrine therapy (ET) per the Investigator's best judgment.
* Participant who relapsed with documented evidence of progression more than 12 months from completion of (neo)adjuvant endocrine/endocrine-based therapy with no treatment for metastatic disease.
* Participant has received prior treatment with fulvestrant, any oral selective estrogen receptor degrader (SERD), any Phosphatidylinositol-3-Kinase (PI3K), mammalian Target of Rapamycin (mTOR) or Protein Kinase B (AKT) inhibitor.

Other Inclusion and Exclusion Criteria do apply
Locations (69)
  • Sint-Niklaas, Oost Vlaanderen, Belgium
  • Brussels, Belgium
  • Brussels, Belgium
  • Ghent, Belgium
  • Leuven, Belgium
  • Liège, Belgium
  • Plovdiv, Bulgaria
  • Sofia, Bulgaria
  • Calgary, Alberta, Canada
  • Ottawa, Ontario, Canada
  • Brno, Czechia
  • Nový Jičín, Czechia
  • Prague, Czechia
  • Prague, Czechia
  • Prague, Czechia
  • Aalborg, Denmark
  • Helsinki, Finland
  • Tampere, Finland
  • Besançon, France
  • Clermont-Ferrand, France
  • La Roche-sur-Yon, France
  • Lyon, France
  • Marseille, France
  • Montpellier, France
  • Paris, France
  • Paris, France
  • Valenciennes, France
  • Cologne, North Rhine-Westphalia, Germany
  • Augsburg, Germany
  • Berlin, Germany
  • + 39 more on CT.gov