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CTRI Number  CTRI/2024/03/063812 [Registered on: 07/03/2024] Trial Registered Prospectively
Last Modified On: 22/04/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To assess the efficacy and safety of inavolisib in combination with Phesgo, in patients with advanced breast cancer  
Scientific Title of Study   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  
Trial Acronym  INAVO 
Secondary IDs if Any  
Secondary ID  Identifier 
NCT05894239  ClinicalTrials.gov 
WO44263_Protocol V1.0 dated 16 Nov 2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kaushal Patel 
Designation  DM, Medical Oncology and Hematology 
Affiliation  Sunshine Global Hospital 
Address  Sunshine Global Hospital (A unit of Baroda Medicare Pvt Ltd), 1st Floor, Oncology Department, Beside Big Bazaar, Dumas - Piplod Road, Surat – 395007, Gujarat, India

Surat
GUJARAT
395007
India 
Phone  9723431102  
Fax    
Email  kpatel291980@gmail.com  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr Jyotii Poddaar 
Designation  Lead- Clinical Operations  
Affiliation  Roche Products (India) Pvt. Ltd 
Address  146 B, 166 A, Unit No. 7, 8, 9 8th Floor, R City Office, R City Mall Lal Bahadur Shastri Marg Ghatkopar Mumbai,Maharashtra Mumbai MAHARASHTRA 400086 India

Mumbai
MAHARASHTRA
400086
India 
Phone  9136064373  
Fax    
Email  jyotii.poddaar@roche.com  
 
Details of Contact Person
Public Query  
Name  Rupesh Choudhary 
Designation  Assistant Manager - Clinical Operations 
Affiliation  Roche Products India Private Limited 
Address  146 B, 166 A, Unit No. 7, 8, 9 8th Floor, R City Office, R City Mall Lal Bahadur Shastri Marg Ghatkopar Mumbai,Maharashtra Mumbai MAHARASHTRA 400086 India

Mumbai
MAHARASHTRA
400086
India 
Phone  9820300215  
Fax    
Email  rupesh.choudhary@roche.com  
 
Source of Monetary or Material Support  
F HoffmannLa Roche Ltd Grenzacherstrasse 124, CH-4070 Basel, Switzerland 
 
Primary Sponsor  
Name  F HoffmannLa Roche Ltd  
Address  Grenzacherstrasse 124, CH-4070 Basel, Switzerland  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Roche Products India Pvt Ltd  146-B, 166 A, Unit No. 7, 8, 9 8th Floor, R City Office, R City Mall Lal Bahadur Shastri Marg Ghatkopar, Mumbai  
 
Countries of Recruitment     Argentina
Australia
Belgium
Brazil
Canada
China
Colombia
Finland
France
Germany
Hong Kong
India
Italy
Kenya
Mexico
Poland
Singapore
South Africa
Spain
Taiwan
Turkey
Uganda
United Kingdom
United States of America
Republic of Korea  
Sites of Study
Modification(s)  
No of Sites = 8  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Priya Tiwari  Artemis Hospital  Artemis Hospital, 4th Floor, HR Building, Sector 51, Gurugram, Haryana 122001, India
Gurgaon
HARYANA 		 8130128241

priya.tiwari@artemishospitals.com 
Dr Meenu Walia  Max Super Speciality Hospital  Max Super Speciality Hospital , Room No. 1101, Ground Floor ( East Wing) , Medical Oncology Department, Patparganj ( A unit of Balaji Medical and Diagnostic Research Centre), 108-A, IP Extension Patparganj, New Delhi- 110092, India
New Delhi
DELHI 		 9818994001

meenu.walia@maxhealthcare.com 
Dr Anand Pathak  National Cancer Institute.  Khasra no.25,Outer Hingna Ring Road, Mouza, Jamtha ,Nagpur-441108
Nagpur
MAHARASHTRA 		 9823038498

abpathak21@gmail.com 
Dr Rahul Ravind  Renai Medicity Hospital  Renai Medicity Hospital, Room No. 341, Ground Floor, C Block, RIMS Department, Palarivattom Edapally Road Near Palarivattom Metro Station Palarivattom P.O, Kochi, Kerala 682025, India
Ernakulam
KERALA 		 9400332824

rahulravind@gmail.com 
Dr Sewanti Limaye  Sir H. N. Reliance Foundation Hospital and Research Centre  Sir H. N. Reliance Foundation Hospital and Research Centre, 3rd floor tower building, Medical Oncology Department, Prarthana Samaj, Raja Rammohan Roy Rd, Girgaon, Mumbai, Maharashtra 400004
Mumbai
MAHARASHTRA 		 9619607339

sewanti.limaye@rfhospital.org 
Dr Kaushal Patel  Sunshine Global Hospital  Sunshine Global Hospital (A unit of Baroda Medicare Pvt Ltd), 1st Floor, Oncology Department, Beside Big Bazaar, Dumas - Piplod Road, Surat – 395007, Gujarat, India
Surat
GUJARAT 		 9723431102

kpatel291980@gmail.com 
Dr Somnath Roy  Tata Medical Center  Tata Medical Center, Department of Medical Oncology Academics & Research Building, 1st Floor, Room No-112,14 Major Arterial Road(E-W), Newtown, Rajarhat, Kolkata-700160
Kolkata
WEST BENGAL 		 9051732283

sroysskm1980@gmail.com 
Dr Harsha Panchal  The Gujarat Cancer and Research Institute  M.P. Shah Cancer Hospital, Civil Hospital campus, Asarwa, Ahmedabad, Gujarat 380016
Ahmadabad
GUJARAT 		 9825940769

harsha.panchal@gcriindia.org 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 8  
Name of Committee  Approval Status 
Artemis Health Sciences IEC  Approved 
GCRI/GCS Ethics committee  Approved 
IEC of Sir H N Reliance Foundation Hospital and RC  Approved 
Institutional Ethics Committee Renai Medicity Hospital   Approved 
Institutional Ethics Committee Sunshine Global Hospital  Approved 
Institutional Ethics Committee, Max Super Speciality Hospital  Approved 
INSTITUTIONAL REVIEW BOARD TATA MEDICAL CENTER  Approved 
National Cancer Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Inavolisib plus Phesgo (experimental arm)  -Inavolisib: 9 mg tablets taken PO once a day (QD) on Days 1−21 of each 21‑day cycle, beginning on Day 1 of Cycle 1 of maintenance treatment - Phesgo: subcutaneously Q3W on Day 1 of each 21‑day cycle 
Comparator Agent  Not Applicable  Not Applicable 
Intervention  Placebo plus Phesgo (control arm)  - Placebo: inavolisib-matching tablets taken PO QD on Days 1−21 of each 21‑day cycle, beginning on Day 1 of Cycle 1 of maintenance treatment - Phesgo: subcutaneously every 3 weeks (Q3W) on Day 1 of each 21‑day cycle 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  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
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Investigator-Assessed Progression-Free Survival (PFS)  Primary PFS analysis:

-Up to approximately 40 months from first patient in (FPI) 
 
Secondary Outcome  
Outcome  TimePoints 
Overall Survival (OS)  Up to approximately 111 months
 
Investigator-Assessed Objective Response Rate (ORR)  Up to approximately 111 months 
Investigator-Assessed Clinical Benefit Rate (CBR)  Up to approximately 111 months 
Investigator-Assessed PFS2  Up to approximately 111 months 
Mean and Mean Changes from Baseline Score in Function and Health-Related Quality of Life (HRQoL)  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. 
Percentage of Participants with Adverse Events  Day 1 until 30 days after the final dose of study treatment (up to approximately 111 months). Each cycle is 21 days. 
Plasma Concentration of Inavolisib at Specified Timepoints  Day 1 of Cycles 1 and 4. Each cycle is 21 days. 
 
Target Sample Size   Total Sample Size="230"
Sample Size from India="6" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/04/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  18/09/2023 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="5"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   WO44263 (INAVO122) 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), aged more than 18 years. 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 ABC.The investigational medicinal products (IMP) for this study are Phesgo, inavolisib, and placebo. Taxane, ET, LHRHa, dexamethasone mouth rinse (if available locally), and anti-hyperglycemics such as metformin are considered noninvestigational medicinal products (NIMP).Treatment will continue until disease progression per RECIST v1.1, unacceptable toxicity, death, withdrawal of consent, or study termination by the Sponsor. The total duration of study participation for the first individual randomized can range from 1 day to 111 months, for the last individual randomized it can range from 1 day to 74 months. 
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