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A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Participants With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer

Status
Closed
Cancer Type
Breast Cancer
Trial Phase
Phase II
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT04191499
Protocol IDs
WO41554 (primary)
NCI-2020-02312
2019-002455-42
Study Sponsor
Hoffmann-La Roche

Summary

This study will evaluate the efficacy, safety, and pharmacokinetics of inavolisib in
combination with palbociclib and fulvestrant compared with placebo plus palbociclib and
fulvestrant in participants with PIK3CA-mutant, hormone receptor (HR)-positive,
HER2-negative locally advanced or metastatic breast cancer whose disease progressed
during treatment or within 12 months of completing adjuvant endocrine therapy and who
have not received prior systemic therapy for metastatic disease.

Eligibility

  1. Confirmed diagnosis of HR+/HER2- breast cancer
  2. Metastatic or locally advanced disease not amenable to curative therapy
  3. Progression of disease during adjuvant endocrine treatment or within 12 months of completing adjuvant endocrine therapy with an aromatase inhibitor or tamoxifen
  4. Receiving LHRH agonist therapy for at least 2 weeks prior to Day 1 of Cycle 1 if pre/peri-menopausal
  5. Confirmation of biomarker eligibility (detection of specified mutation(s) of PIK3CA via specified test)
  6. Consent to provide fresh or archival tumor tissue specimen
  7. Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1); evaluable "bone-only" disease is not eligible; "bone-only" disease with at least one measurable, soft-tissue component, even if considered disease that is limited to bone but has lytic or mixed lytic/blastic lesions and at least one measurable soft-tissue component per RECIST v1.1 may be eligible
  8. Eastern Cooperative Oncology Group Performance Status of 0 or 1
  9. Life expectancy of > 6 months
  10. Adequate hematologic and organ function within 14 days prior to initiation of study treatment

Treatment Sites in Georgia

Northwest Georgia Oncology Centers - Cobb Hospital (Hiram)


144 Bill Carruth Parkway
Suite 3100
Hiram, GA 30141
770-281-5131
www.ngoc.com

Doctors:

Kathleen A. Long MD
Aron E. Kefela MD

Northwest Georgia Oncology Centers - Tanner Medical Center Villa Rica


157 Clinic Avenue
Suite 101 and Suite 102
Carrollton, GA 30117
770-281-5101
www.ngoc.com

Doctors:

Bradley J.G. Larson MD
Randall E. Pierce MD
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.