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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06790693




Registration number
NCT06790693
Ethics application status
Date submitted
14/01/2025
Date registered
24/01/2025
Date last updated
22/06/2025

Titles & IDs
Public title
A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer
Scientific title
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus a CDK4/6 Inhibitor and Letrozole Versus Placebo Plus a CDK4/6 Inhibitor and Letrozole in Patients With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer
Secondary ID [1] 0 0
2024-516162-11-00
Secondary ID [2] 0 0
WO45654
Universal Trial Number (UTN)
Trial acronym
INAVO123
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Inavolisib
Treatment: Drugs - Placebo
Treatment: Drugs - CDK4/6i
Treatment: Drugs - Letrozole

Experimental: Inavolisib + Letrozole + CDK4/6i - Participants will receive inavolisib, letrozole and CDK4/6i.

Placebo comparator: Placebo + Letrozole + CDK4/6i - Participants will receive placebo, letrozole and CDK4/6i.


Treatment: Drugs: Inavolisib
Participants will receive oral inavolisib once daily (QD).

Treatment: Drugs: Placebo
Participants will receive oral placebo QD.

Treatment: Drugs: CDK4/6i
Participants will receive oral palbociclib on Days 1-21 of each 28-day cycle.

Treatment: Drugs: Letrozole
Participants will receive oral letrozole QD.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS)
Timepoint [1] 0 0
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 7 years)
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
From randomization to death from any cause (up to 7 years)
Secondary outcome [2] 0 0
Investigator-assessed Objective Response Rate (ORR)
Timepoint [2] 0 0
Up to 7 years
Secondary outcome [3] 0 0
Investigator-assessed Duration of Response (DOR)
Timepoint [3] 0 0
From the first occurrence of a confirmed objective response to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 7 years)
Secondary outcome [4] 0 0
Investigator-assessed Clinical Benefit Rate (CBR)
Timepoint [4] 0 0
Up to 7 years
Secondary outcome [5] 0 0
Time to Confirmed Deterioration (TTCD) in Pain
Timepoint [5] 0 0
From baseline until end of follow-up (up to 7 years)
Secondary outcome [6] 0 0
TTCD in Physical Function
Timepoint [6] 0 0
From baseline until end of follow-up (up to 7 years)
Secondary outcome [7] 0 0
TTCD in Role Function
Timepoint [7] 0 0
From baseline until end of follow-up (up to 7 years)
Secondary outcome [8] 0 0
TTCD in Global Health Status
Timepoint [8] 0 0
From baseline until end of follow-up (up to 7 years)
Secondary outcome [9] 0 0
Percentage of Participants with Adverse Events
Timepoint [9] 0 0
From baseline until end of follow-up (up to 7 years)
Secondary outcome [10] 0 0
Number of Participants Reporting Presence, Frequency, Severity, and/or Degree of Interference with Daily Function of Symptomatic Treatment Toxicities Assessed by NCI Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Timepoint [10] 0 0
Up to 7 years
Secondary outcome [11] 0 0
Number of Participants Reporting Each Response Option for Treatment Side-effect Bother Single-item General Population, Question 5 (GP5) from the Functional Assessment of Cancer Therapy-General Questionnaire; (FACT-G)
Timepoint [11] 0 0
Up to 7 years
Secondary outcome [12] 0 0
Change from Baseline in Symptomatic Treatment Toxicities as Assessed Through use of the PRO-CTCAE
Timepoint [12] 0 0
Baseline up to 7 years
Secondary outcome [13] 0 0
Change from Baseline in Treatment Side-effect Bother as Assessed Through use of the FACT-G GP5 Item
Timepoint [13] 0 0
Baseline up to 7 years

Eligibility
Key inclusion criteria
* Women or men with histologically or cytologically confirmed carcinoma of the breast
* Documented ER-positive and/or progesterone receptor-positive tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines
* Documented HER2-negative tumor according to ASCO/CAP guidelines
* De-novo HR+ , HER2- ABC, or, alternatively, relapsed HR+ , HER2- ABC after at least 2 years of standard neoadjuvant/adjuvant endocrine therapy without disease progression during that treatment and disease-free interval of at least 1 year since the completion of that treatment
* Participants who have bilateral breast cancers which are both HR-positive and HER2-negative
* Confirmation of biomarker eligibility
* Consent to provide fresh or archival tumor tissue specimen
* Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Adequate hematologic and organ function within 14 days prior to initiation of study treatment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required
* Metaplastic breast cancer
* Any prior systemic therapy for locally advanced unresectable or metastatic breast cancer
* Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
* Any history of leptomeningeal disease or carcinomatous meningitis
* Known and untreated, or active CNS metastases. Participants with a history of treated CNS metastases are eligible
* Active inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye
* Symptomatic active lung disease
* History of or active inflammatory bowel disease
* Any active bowel inflammation
* Prior hematopoietic stem cell or bone marrow transplantation
* Treatment with strong cytochrome P450 (CYP) 3A4 inhibitors or strong CYP3A4 inducers within 4 weeks or 5 drug-elimination half-lives, prior to initiation of study treatment

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/04/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/05/2032
Actual
Sample size
Target
450
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 0 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment postcode(s) [2] 0 0
5112 - Elizabeth Vale
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Nebraska
Country [4] 0 0
United States of America
State/province [4] 0 0
Tennessee
Country [5] 0 0
Argentina
State/province [5] 0 0
Caba
Country [6] 0 0
Brazil
State/province [6] 0 0
Bahia
Country [7] 0 0
Brazil
State/province [7] 0 0
Ceará
Country [8] 0 0
Brazil
State/province [8] 0 0
Espírito Santo
Country [9] 0 0
Brazil
State/province [9] 0 0
Goiás
Country [10] 0 0
Brazil
State/province [10] 0 0
Minas Gerais
Country [11] 0 0
Brazil
State/province [11] 0 0
Paraná
Country [12] 0 0
Brazil
State/province [12] 0 0
Pernambuco
Country [13] 0 0
Brazil
State/province [13] 0 0
Piauí
Country [14] 0 0
Brazil
State/province [14] 0 0
Rio Grande Do Sul
Country [15] 0 0
Brazil
State/province [15] 0 0
São Paulo
Country [16] 0 0
Brazil
State/province [16] 0 0
Rio de Janeiro
Country [17] 0 0
Canada
State/province [17] 0 0
Ontario
Country [18] 0 0
Canada
State/province [18] 0 0
Quebec
Country [19] 0 0
China
State/province [19] 0 0
Hubei
Country [20] 0 0
China
State/province [20] 0 0
Beijing City
Country [21] 0 0
China
State/province [21] 0 0
Changsha CITY
Country [22] 0 0
China
State/province [22] 0 0
Chengdu City
Country [23] 0 0
China
State/province [23] 0 0
Chengdu
Country [24] 0 0
China
State/province [24] 0 0
Guangzhou
Country [25] 0 0
China
State/province [25] 0 0
Hangzhou City
Country [26] 0 0
China
State/province [26] 0 0
Harbin
Country [27] 0 0
China
State/province [27] 0 0
Jiangmen
Country [28] 0 0
China
State/province [28] 0 0
Jinan
Country [29] 0 0
China
State/province [29] 0 0
Jinhua City
Country [30] 0 0
China
State/province [30] 0 0
Kunming
Country [31] 0 0
China
State/province [31] 0 0
Nanning City
Country [32] 0 0
China
State/province [32] 0 0
Shantou City
Country [33] 0 0
China
State/province [33] 0 0
Tianjin
Country [34] 0 0
China
State/province [34] 0 0
Urumqi City
Country [35] 0 0
China
State/province [35] 0 0
Xi'an City
Country [36] 0 0
China
State/province [36] 0 0
Xian
Country [37] 0 0
Korea, Republic of
State/province [37] 0 0
Daegu
Country [38] 0 0
Korea, Republic of
State/province [38] 0 0
Dongnam-gu, Cheonan-si
Country [39] 0 0
Korea, Republic of
State/province [39] 0 0
Goyang-si
Country [40] 0 0
Korea, Republic of
State/province [40] 0 0
Seongnam-si
Country [41] 0 0
Korea, Republic of
State/province [41] 0 0
Seoul
Country [42] 0 0
South Africa
State/province [42] 0 0
Richards Bay
Country [43] 0 0
Taiwan
State/province [43] 0 0
Chiayi
Country [44] 0 0
Taiwan
State/province [44] 0 0
Taichung
Country [45] 0 0
Taiwan
State/province [45] 0 0
Tainan
Country [46] 0 0
Taiwan
State/province [46] 0 0
Taipei
Country [47] 0 0
Turkey
State/province [47] 0 0
Ankara
Country [48] 0 0
Turkey
State/province [48] 0 0
Bakirkoy / Istanbul
Country [49] 0 0
Turkey
State/province [49] 0 0
Istanbul
Country [50] 0 0
Turkey
State/province [50] 0 0
Izmir
Country [51] 0 0
Turkey
State/province [51] 0 0
Mersin
Country [52] 0 0
United Kingdom
State/province [52] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Reference Study ID Number: WO45654 https://forpatients.roche.com/
Address 0 0
Country 0 0
Phone 0 0
888-662-6728 (U.S. Only)
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06790693