Inavolisib and Phesgo for Advanced Breast Cancer

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

Recruiting Phase 3 Interventional Study
Metastatic Breast Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
230 (estimated)
Sponsor
Hoffmann-La Roche · Industry
Who this trial is looking for

This trial is looking for people with advanced breast cancer that is HER2-positive and has a specific mutation. Participants will take a combination of medicines after their initial treatment.

Are You a Good Fit for This Trial?
Rules you out Type 1 diabetesActive HBV infectionSevere liver diseaseActive inflammatory bowel disease

You may be able to join if

  • I have been diagnosed with breast cancer that has spread or is locally advanced.
  • I have a specific mutation called PIK3CA.
  • I have not received treatment for my advanced breast cancer before this trial.
  • I am between 0 and 1 on the ECOG performance scale.
  • I have good heart function as checked by an echo or scan.
  • I have had at least 6 months without cancer after my last treatment.

You may not be able to join if

  • I have received prior treatment that affects the PI3K pathway.
  • I have had cancer treatment for advanced breast cancer before this trial.
  • I have a history of active inflammatory bowel disease.
  • I had cancer progression within 6 months after receiving HER2-targeted therapy.
  • I have Type 1 diabetes or Type 2 diabetes needing treatment.
  • I have an active HBV infection.
  • I have severe liver disease or significant liver problems.
  • I experienced serious infections in the week before starting.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

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).

Trial Locations
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Eligibility Criteria
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 eligibili…
Contacts

Reference Study ID Number: WO44263 https://forpatients.roche.com/ No attachments to email below.

888-662-6728 (U.S. Only)

global-roche-genentech-trials@gene.com

CONTACT

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT