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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04191499




Registration number
NCT04191499
Ethics application status
Date submitted
2/12/2019
Date registered
9/12/2019

Titles & IDs
Public title
A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer
Scientific title
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer
Secondary ID [1] 0 0
2019-002455-42
Secondary ID [2] 0 0
WO41554
Universal Trial Number (UTN)
Trial acronym
INAVO120
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 - Palbociclib
Treatment: Drugs - Fulvestrant

Experimental: Inavolisib + Palbociclib + Fulvestrant - Participants will receive inavolisib, palbociclib, and fulvestrant.

Placebo comparator: Placebo + Palbociclib + Fulvestrant - Participants will receive placebo, palbociclib, and fulvestrant.


Treatment: Drugs: Inavolisib
Participants will receive oral inavolisib on Days 1-28 of each 28-day cycle.

Treatment: Drugs: Placebo
Participants will receive oral placebo on Days 1-28 of each 28-day cycle.

Treatment: Drugs: Palbociclib
Participants will receive oral palbociclib on Days 1-21 of each 28-day cycle.

Treatment: Drugs: Fulvestrant
Participants will receive intramuscular (IM) fulvestrant approximately every 4 weeks.
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
Up to 3.7 years
Secondary outcome [1] 0 0
Percentage of Participants With Objective Response Rate (ORR)
Timepoint [1] 0 0
Up to approximately 6 years
Secondary outcome [2] 0 0
Percentage of Participants With Best Overall Response Rate (BOR)
Timepoint [2] 0 0
Up to approximately 6 years
Secondary outcome [3] 0 0
Duration of Response (DOR)
Timepoint [3] 0 0
Up to approximately 6 years
Secondary outcome [4] 0 0
Percentage of Participants With Clinical Benefit Rate (CBR)
Timepoint [4] 0 0
Up to approximately 6 years
Secondary outcome [5] 0 0
Overall Survival (OS)
Timepoint [5] 0 0
Up to approximately 6 years
Secondary outcome [6] 0 0
Time to Deterioration (TTD) in Pain
Timepoint [6] 0 0
From randomization to first documentation of a = 2-point increase (Up to approximately 6 years)
Secondary outcome [7] 0 0
TTD in Physical Function (PF)
Timepoint [7] 0 0
Treatment: Day 1 of Cycles 1-3, then Day 1 of every other cycle until treatment discontinuation. Post-treatment: Every 8 weeks for 2 years, then every 12 weeks thereafter, to end of study (up to 6 years) (Cycle length = 28 days)]
Secondary outcome [8] 0 0
TTD in Role Function (RF)
Timepoint [8] 0 0
Treatment: Day 1 of Cycles 1-3, then Day 1 of every other cycle until treatment discontinuation. Post-treatment: Every 8 weeks for 2 years, then every 12 weeks thereafter, to end of study (up to 6 years) (Cycle length = 28 days)]
Secondary outcome [9] 0 0
TTD in Global Health Status (GHS)
Timepoint [9] 0 0
Treatment: Day 1 of Cycles 1-3, then Day 1 of every other cycle until treatment discontinuation. Post-treatment: Every 8 weeks for 2 years, then every 12 weeks thereafter, to end of study (up to 6 years) (Cycle length = 28 days)]
Secondary outcome [10] 0 0
Number of Participants With Adverse Events (AEs)
Timepoint [10] 0 0
Up to approximately 6 years
Secondary outcome [11] 0 0
Plasma Concentration of Inavolisib
Timepoint [11] 0 0
Predose on Cycle 1 Days 1, 8 and 15 and Cycle 2 Day 15; 3 hours post-dose on Cycle 1 Days 1 and 15 (Cycle length = 28 days)
Secondary outcome [12] 0 0
Plasma Concentration of Palbociclib
Timepoint [12] 0 0
Predose on Cycle 1 Days 1, 8 and 15 and Cycle 2 Day 15; 3 hours post-dose on Cycle 1 Days 1 and 15 (Cycle length = 28 days)
Secondary outcome [13] 0 0
Plasma Concentration of Fulvestrant
Timepoint [13] 0 0
Predose on Cycle 1 Days 1, 8 and 15 and Cycle 2 Day 15; 3 hours post-dose on Cycle 1 Days 1 and 15 (Cycle length = 28 days)

Eligibility
Key inclusion criteria
Inclusion Criteria

* Confirmed diagnosis of HR+/HER2- breast cancer
* Metastatic or locally advanced disease not amenable to curative therapy
* Progression of disease during adjuvant endocrine treatment or within 12 months of completing adjuvant endocrine therapy with an aromatase inhibitor or tamoxifen
* Receiving LHRH agonist therapy for at least 2 weeks prior to Day 1 of Cycle 1 if pre/peri-menopausal
* Confirmation of biomarker eligibility (detection of specified mutation(s) of PIK3CA via specified test)
* Consent to provide fresh or archival tumor tissue specimen
* Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1); evaluable "bone-only" disease is not eligible; "bone-only" disease with at least one measurable, soft-tissue component, even if considered disease that is limited to bone but has lytic or mixed lytic/blastic lesions and at least one measurable soft-tissue component per RECIST v1.1 may be eligible
* Eastern Cooperative Oncology Group Performance Status of 0 or 1
* Life expectancy of > 6 months
* 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
Exclusion Criteria

* Metaplastic breast cancer
* Any history of leptomeningeal disease or carcinomatous meningitis
* Any prior systemic therapy for metastatic breast cancer
* Prior treatment with fulvestrant or any selective estrogen-receptor degrader, with the exception of participants that have received fulvestrant or any selective estrogen-receptor degrader as part of neoadjuvant therapy only and with treatment duration of no longer than 6 months
* Prior treatment with any PI3K, AKT, or mTOR inhibitor, or any agent whose mechanism of action is to inhibit the PI3K-AKT-mTOR pathway
* Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
* Known and untreated, or active CNS metastases. Patients with a history of treated CNS metastases may be eligible
* Active inflammatory or infectious conditions in either eye, or any eye conditions expected to require surgery during the study treatment period
* Symptomatic active lung disease, or requiring daily supplemental oxygen
* History of inflammatory bowel disease or active bowel inflammation
* Anti-cancer therapy within 2 weeks before study entry
* Investigational drug(s) within 4 weeks before randomization
* Prior radiotherapy to >= 25% of bone marrow, or hematopoietic stem cell or bone marrow transplantation
* Chronic corticosteroid therapy or immunosuppressants
* Pregnant, lactating, or breastfeeding, or intending to become pregnant during the study or within 60 days after the final dose of study treatment
* Major surgical procedure, or significant traumatic injury, within 28 days prior to Day 1 of Cycle 1

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 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/01/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2030
Actual
Sample size
Target
Accrual to date
Final
325
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Macquarie University Hospital - Macquarie Park
Recruitment hospital [2] 0 0
Westmead Hospital; Medical Oncology and Pallative Care - Westmead
Recruitment hospital [3] 0 0
Southern Medical Day Care Centre - Wollongong
Recruitment hospital [4] 0 0
Mater Adult Hospital; Oncology - South Brisbane
Recruitment hospital [5] 0 0
Princess Alexandra Hospital; Cancer Trials Unit - Woolloongabba
Recruitment hospital [6] 0 0
Western Health - Fitzroy
Recruitment hospital [7] 0 0
Peninsula and South Eastern Haematology and Oncology Group - Frankston
Recruitment postcode(s) [1] 0 0
2113 - Macquarie Park
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
2500 - Wollongong
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [6] 0 0
3065 - Fitzroy
Recruitment postcode(s) [7] 0 0
3199 - Frankston
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
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Massachusetts
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United States of America
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New York
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United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Tennessee
Country [7] 0 0
United States of America
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Texas
Country [8] 0 0
United States of America
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Washington
Country [9] 0 0
Argentina
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Buenos Aires
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Argentina
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Ciudad Autonoma Buenos Aires
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Argentina
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Rosario
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Belgium
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Leuven
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Brazil
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GO
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RS
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SP
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Changchun City
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Shijiazhuang
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Tianjin
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China
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Wuhan City
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China
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Wuhan
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China
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Xi'an
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China
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Zhengzhou
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Vejle
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Sevilla
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Bangkok
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Thailand
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Chiang Mai
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Thailand
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Lak Si
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Thailand
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Songkhla
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Turkey
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Adana
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Ankara
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Turkey
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Bornova, ?zm?r
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Turkey
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Istanbul
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Ukraine
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Kharkiv Governorate
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Ukraine
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KIEV Governorate
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Ukraine
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Dnipropetrovsk
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Ukraine
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Kryvyi Rih
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Ukraine
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Kyiv
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Ukraine
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Sumy
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United Kingdom
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Harlow
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London
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Oxford
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Peterborough
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United Kingdom
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Plymouth

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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04191499