To assess the efficacy and safety of inavolisib in combination with Phesgo, in patients with advanced breast cancer

Phase 3

Conditions: Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

Registration Number: CTRI/2024/03/063812

Lead Sponsor: F HoffmannLa Roche Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1

2. Histologically or cytologically confirmed and documented adenocarcinoma of the breast with metastatic or locally advanced disease not amenable to curative resection

3. Confirmation of HER2 biomarker eligibility based on valid results from central testing of tumor tissue documenting HER2-positivity

4. Confirmation of PIK3CA mutation biomarker eligibility based on valid results from central testing of tumor tissue documenting PIK3CA mutated tumor status

5. Disease free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence of more than equal to 6 months

6. LVEF (left ventricular ejection fraction) of at least 50 percent measured by echocardiogram (ECHO) or multiple gated acquisition scan (MUGA)

7. Adequate hematologic and organ function prior to initiation of study treatment

8. Negative hepatitis B surface antigen (HBsAg) test and negative total hepatitis B core antibody (HBcAb) at screening

9. Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by a negative (per local laboratory definition) hepatitis B virus (HBV) DNA test at screening

10. Negative hepatitis C virus (HCV) antibody test at screening, or a positive HCV antibody test followed by a negative HCV RNA test at screening

Exclusion Criteria

1. 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

2. Any prior systemic non-hormonal anti-cancer therapy for locally advanced or metastatic HER2-positive breast cancer prior to initiation of induction therapy

3. History or active inflammatory bowel disease

4. Disease progression within 6 months of receiving any HER2-targeted therapy

5. Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes

6. 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

7. Any history of leptomeningeal disease or carcinomatous meningitis

Serious infection requiring IV antibiotics within 7 days prior to Day 1 of Cycle 1

8. 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

9. Active inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye

10. Inability or unwillingness to swallow pills.

11. History of malignancy within 5 years prior to screening, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer. The medical monitor may be consulted if required

12. History of prior significant toxicity related to trastuzumab or pertuzumab requiring discontinuation of treatment

13. Major surgical procedure, or significant traumatic injury, within 28 days prior to start of study treatment or anticipation of the need for major surgery during the course of study treatment