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The trial is taking place at:
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Hightower Clinical | Oklahoma City, OK

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A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer

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Roche

Status and phase

Enrolling
Phase 3

Conditions

Metastatic Breast Cancer

Treatments

Drug: Inavolisib
Drug: Optional Endocrine Therapy of Investigator's Choice
Drug: Taxane-based Chemotherapy
Drug: Phesgo
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT05894239
2022-502046-28-00 (Registry Identifier)
WO44263

Details and patient eligibility

About

This study will evaluate the efficacy and safety of inavolisib in combination with Phesgo (pertuzumab, trastuzumab, and rHuPH20 injection for subcutaneous use) compared with placebo in combination with Phesgo, as maintenance therapy, after induction therapy in participants with previously untreated HER2-positive advanced breast cancer (ABC).

Enrollment

230 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
  • Histologically or cytologically confirmed and documented adenocarcinoma of the breast with metastatic or locally advanced disease not amenable to curative resection
  • Confirmation of HER2 biomarker eligibility based on valid results from central testing of tumor tissue documenting HER2-positivity
  • Confirmation of PIK3CA-mutation biomarker eligibility based on valid results from central testing of tumor tissue documenting PIK3CA-mutated tumor status
  • Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence of >= 6 months
  • LVEF (left ventricular ejection fraction) of at least 50% measured by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA)
  • Adequate hematologic and organ function prior to initiation of study treatment

Exclusion criteria

  • Prior treatment in the locally advanced or metastatic setting with any PI3K, AKT, or mTOR inhibitor or any agent whose mechanism of action is to inhibit the PI3K-AKT-mTOR pathway
  • Any prior systemic non-hormonal anti-cancer therapy for locally advanced or metastatic HER2-positive breast cancer prior to initiation of induction therapy
  • History or active inflammatory bowel disease
  • Disease progression within 6 months of receiving any HER2-targeted therapy
  • Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
  • Participants with active HBV infection
  • Clinically significant and active liver disease, including severe liver impairment, viral or other hepatitis, current alcohol abuse, or cirrhosis
  • Symptomatic active lung disease, including pneumonitis or interstitial lung disease
  • Any history of leptomeningeal disease or carcinomatous meningitis
  • Serious infection requiring IV antibiotics within 7 days prior to Day 1 of Cycle 1
  • Any concurrent ocular or intraocular condition that, in the opinion of the investigator, would require medical or surgical intervention during the study period to prevent or treat vision loss that might result from that condition
  • Active inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

230 participants in 3 patient groups

Induction Therapy: Phesgo plus Taxane-Based Chemotherapy
Other group
Description:
Participants will be administered the treatments as outlined in the interventions section.
Treatment:
Drug: Phesgo
Drug: Taxane-based Chemotherapy
Maintenance Therapy: Inavolisib plus Phesgo
Experimental group
Description:
Participants will be administered the treatments as outlined in the interventions section.
Treatment:
Drug: Phesgo
Drug: Optional Endocrine Therapy of Investigator's Choice
Drug: Inavolisib
Maintenance Therapy: Placebo plus Phesgo
Active Comparator group
Description:
Participants will be administered the treatments as outlined in the interventions section.
Treatment:
Drug: Placebo
Drug: Phesgo
Drug: Optional Endocrine Therapy of Investigator's Choice

Trial contacts and locations

135

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Central trial contact

Reference Study ID Number: WO44263 https://forpatients.roche.com/

Data sourced from clinicaltrials.gov

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