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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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ClinicalTrials.gov Identifier: NCT05894239
Recruitment Status : Recruiting
First Posted : June 8, 2023
Last Update Posted : November 13, 2023
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: Inavolisib Drug: Phesgo Drug: Placebo Drug: Taxane-based Chemotherapy Drug: Optional Endocrine Therapy of Investigator's Choice Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo As Maintenance Therapy After First Line Induction Therapy in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer
Actual Study Start Date : July 28, 2023
Estimated Primary Completion Date : October 31, 2028
Estimated Study Completion Date : October 31, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Induction Therapy: Phesgo plus Taxane-Based Chemotherapy
Participants will be administered the treatments as outlined in the interventions section.
Drug: Phesgo
Phesgo will be administered to participants subcutaneously every 3 weeks (Q3W) on D1 of each 21-day cycle.

Drug: Taxane-based Chemotherapy
During the induction therapy phase, the investigator's choice of taxane-based chemotherapy will be administered after Phesgo.
Other Name: non-investigational medicinal product (NIMP)

Experimental: Maintenance Therapy: Inavolisib plus Phesgo
Participants will be administered the treatments as outlined in the interventions section.
Drug: Inavolisib
Participants will receive an inavolisib tablet to be taken orally (PO), once a day (QD), on Days 1-21 of each 21-day cycle, beginning on Day (D) 1 of Cycle (C) 1 of maintenance treatment.

Drug: Phesgo
Phesgo will be administered to participants subcutaneously every 3 weeks (Q3W) on D1 of each 21-day cycle.

Drug: Optional Endocrine Therapy of Investigator's Choice
Optional endocrine therapy (ET) is allowed at the discretion of the investigator, based on the standard of care. Allowed ETs are tamoxifen, or one of the specified third-generation aromatase inhibitor (AI [anastrozole, letrozole, or exemestane]), or fulvestrant. The investigator will determine and supply the appropriate luteinizing hormone-releasing hormone (LHRH) agonist locally approved for use in breast cancer. The LHRH agonist will be administered according to local prescribing information.
Other Name: NIMP

Active Comparator: Maintenance Therapy: Placebo plus Phesgo
Participants will be administered the treatments as outlined in the interventions section.
Drug: Phesgo
Phesgo will be administered to participants subcutaneously every 3 weeks (Q3W) on D1 of each 21-day cycle.

Drug: Placebo
Inavolisib-matching tablet taken PO QD on Days 1-21 of each 21-day cycle, beginning on D1 C1 of maintenance treatment.

Drug: Optional Endocrine Therapy of Investigator's Choice
Optional endocrine therapy (ET) is allowed at the discretion of the investigator, based on the standard of care. Allowed ETs are tamoxifen, or one of the specified third-generation aromatase inhibitor (AI [anastrozole, letrozole, or exemestane]), or fulvestrant. The investigator will determine and supply the appropriate luteinizing hormone-releasing hormone (LHRH) agonist locally approved for use in breast cancer. The LHRH agonist will be administered according to local prescribing information.
Other Name: NIMP




Primary Outcome Measures :
  1. Investigator-Assessed Progression-Free Survival (PFS) [ Time Frame: Up to approximately 40 months ]

Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Up to approximately 111 months ]
  2. Investigator-Assessed Objective Response Rate (ORR) [ Time Frame: Up to approximately 111 months ]
  3. Investigator-Assessed Duration of Response (DOR) [ Time Frame: Up to approximately 111 months ]
  4. Investigator-Assessed Clinical Benefit Rate (CBR) [ Time Frame: Up to approximately 111 months ]
  5. Investigator-Assessed PFS2 [ Time Frame: Up to approximately 111 months ]
  6. Mean and Mean Changes from Baseline Score in Function and Health-Related Quality of Life (HRQoL) [ Time Frame: Day 1 of Cycles 1 and 2 and beyond, 30-day safety follow up visit, post-treatment tumor assessment follow-up with PRO collection and survival follow up visit every 6 months (up to 111 months). Each cycle is 21 days. ]
    Assessed through the use of the Functional (Role, Physical) and Global Health Status (GHS)/Quality of Life (QoL) scales of the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30)

  7. Percentage of Participants with Adverse Events [ Time Frame: Day 1 until 30 days after the final dose of study treatment (up to approximately 111 months). Each cycle is 21 days. ]
  8. Plasma Concentration of Inavolisib at Specified Timepoints [ Time Frame: Day 1 of Cycles 1 and 4. Each cycle is 21 days. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05894239


Contacts
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Contact: Reference Study ID Number: WO44263 https://forpatients.roche.com/ 888-662-6728 (U.S. Only) global-roche-genentech-trials@gene.com

Locations
Show Show 56 study locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT05894239    
Other Study ID Numbers: WO44263
2022-502046-28-00 ( Registry Identifier: EU Clinical Trials )
First Posted: June 8, 2023    Key Record Dates
Last Update Posted: November 13, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/innovation/process/clinical-trials/data-sharing/).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Taxane
Inavolisib
Antineoplastic Agents
Phosphoinositide-3 Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action