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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04436744




Registration number
NCT04436744
Ethics application status
Date submitted
16/06/2020
Date registered
18/06/2020

Titles & IDs
Public title
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Giredestrant Plus Palbociclib Compared With Anastrozole Plus Palbociclib for Postmenopausal Women With Estrogen Receptor-Positive and HER2-Negative Untreated Early Breast Cancer (coopERA Breast Cancer)
Scientific title
A Randomized, Multicenter, Open-Label, Two-Arm, Phase II, Neoadjuvant Study Evaluating the Efficacy, Safety, and Pharmacokinetics of GDC-9545 Plus Palbociclib Compared With Anastrozole Plus Palbociclib for Postmenopausal Women With Estrogen Receptor-Positive and HER2-Negative Untreated Early Breast Cancer
Secondary ID [1] 0 0
2020-001007-16
Secondary ID [2] 0 0
WO42133
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Early 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 - Giredestrant
Treatment: Drugs - Anastrozole
Treatment: Drugs - Palbociclib
Treatment: Surgery - Surgery

Experimental: Giredestrant + Palbociclib -

Active comparator: Anastrozole + Palbociclib -


Treatment: Drugs: Giredestrant
During the window-of-opportunity phase (first 2 weeks) giredestrant will be taken orally once per day (QD) as a single agent. During the neoadjuvant treatment phase, giredestrant will be taken orally QD on Days 1-28 of each 28-day cycle for a total of 4 cycles, in combination with palbociclib.

Treatment: Drugs: Anastrozole
During the window-of-opportunity phase (first 2 weeks), anastrozole 1 mg will be taken orally QD as a single agent. During the neoadjuvant treatment phase, anastrozole 1 mg will be taken orally QD on Days 1-28 of each 28-day cycle for a total of 4 cycles, in combination with palbociclib.

Treatment: Drugs: Palbociclib
During the neoadjuvant treatment phase, palbociclib 125 mg will be taken orally QD on Days 1-21 of a 28-day cycle for a total of 4 cycles.

Treatment: Surgery: Surgery
Surgery must be performed within a maximum of 14 days after the final cycle in the neoadjuvant treatment phase and ideally should occur as soon as possible after the last dose of study treatment.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Relative Percent Change in Ki67 Scores From Baseline to Week 2
Timepoint [1] 0 0
Baseline, Week 2
Secondary outcome [1] 0 0
Overall Response Rate (ORR) by Ultrasound as Determined by the Investigator
Timepoint [1] 0 0
Baseline up to Cycle 4 Day 1 (each cycle is 28 days)
Secondary outcome [2] 0 0
Complete Cell Cycle Arrest (CCCA) Rate at Week 2
Timepoint [2] 0 0
Week 2
Secondary outcome [3] 0 0
Number of Participants With Adverse Events (AEs) With Severity Determined in Accordance With National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)
Timepoint [3] 0 0
From baseline up to 28 days after the last dose (up to approximately 24 weeks)
Secondary outcome [4] 0 0
Change From Baseline in Respiratory Rate Over Time
Timepoint [4] 0 0
Baseline; Cycles 1-2: Day 1 and Day 15; Cycles 3-4: Day 1; day of surgery (up to 2 weeks after the final dose of study treatment [approximately Week 18]) and end of study (up to approximately 24 weeks)
Secondary outcome [5] 0 0
Change From Baseline in Pulse Rate Over Time
Timepoint [5] 0 0
Baseline; Cycles 1-2: Day 1 and Day 15; Cycles 3-4: Day 1; day of surgery (up to 2 weeks after the final dose of study treatment [approximately Week 18]) and end of study (up to approximately 24 weeks)
Secondary outcome [6] 0 0
Change From Baseline in Systolic Blood Pressure Over Time
Timepoint [6] 0 0
Baseline; Cycles 1-2: Day 1 and Day 15; Cycles 3-4: Day 1; day of surgery (up to 2 weeks after the final dose of study treatment [approximately Week 18]) and end of study (up to approximately 24 weeks)
Secondary outcome [7] 0 0
Change From Baseline in Diastolic Blood Pressure Over Time
Timepoint [7] 0 0
Baseline; Cycles 1-2: Day 1 and Day 15; Cycles 3-4: Day 1; day of surgery (up to 2 weeks after the final dose of study treatment [approximately Week 18]) and end of study (up to approximately 24 weeks)
Secondary outcome [8] 0 0
Change From Baseline in Body Temperature Over Time
Timepoint [8] 0 0
Baseline; Cycles 1-2: Day 1 and Day 15; Cycles 3-4: Day 1; day of surgery (up to 2 weeks after the final dose of study treatment [approximately Week 18]) and end of study (up to approximately 24 weeks)
Secondary outcome [9] 0 0
Number of Participants With Shifts in Hematology Test Parameters From NCI-CTCAE Grade 0-2 at Baseline to Grade 3-4 at Post-baseline
Timepoint [9] 0 0
From baseline up to 28 days after the last dose (up to approximately 24 weeks)
Secondary outcome [10] 0 0
Number of Participants With Shifts in Blood Chemistry Parameters From NCI-CTCAE Grade 0-2 at Baseline to Grade 3-4 at Post-baseline
Timepoint [10] 0 0
From baseline up to 28 days after the last dose (up to approximately 24 weeks)
Secondary outcome [11] 0 0
Plasma Concentration of Giredestrant at Specified Timepoints
Timepoint [11] 0 0
Window of Opportunity Phase: Day 1 (3 hours Postdose) and Day 15 (Predose) during Cycle 0 (the 15-day period in Window of Opportunity Phase is called Cycle 0 for PK analysis); Neoadjuvant Phase: Cycle 2 Day 1, Predose

Eligibility
Key inclusion criteria
* Postmenopausal women age =18 years
* Histologically confirmed operable or inoperable invasive breast carcinoma
* Candidate for neoadjuvant treatment and considered appropriate for endocrine therapy
* Willingness to undergo breast surgery after neoadjuvant treatment and to provide three mandatory tumor samples
* Documented estrogen receptor (ER)-positive tumor in accordance to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines (Allison et al.2020), assessed locally and defined as =1% of tumor cells stained positive on the basis of the most recent tumor biopsy
* Documented progesterone receptor status (positive or negative) as per local assessment
* Documented human epidermal growth factor receptor-2 (HER2)-negative tumor in accordance to 2018 ASCO/CAP guidelines (Wolff et al. 2018), assessed locally on the most recent tumor biopsy
* Ki67 score =5% analyzed centrally or locally
* Eastern Cooperative Oncology Group Performance Status 0-1
* Adequate organ function
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Stage IV (metastatic) breast cancer
* Inflammatory breast cancer (cT4d)
* Bilateral invasive breast cancer
* History of invasive breast cancer, ductal carcinoma in situ or lobular carcinoma in situ and other malignancy within 5 years prior to screening
* Previous systemic or local treatment for the primary breast cancer currently under investigation
* History of any prior treatment with aromatase inhibitors (AIs), tamoxifen, selective estrogen receptor down regulator, or cyclin-dependent kinase 4 and 6 inhibitors
* Major surgery within 4 weeks prior to randomization
* Known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including hepatitis
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study
* History of allergy to anastrozole, or palbociclib or any of its excipients
* Known issues with swallowing oral medication
* History of documented hemorrhagic diathesis, coagulopathy, or thromboembolism
* Active cardiac disease or history of cardiac dysfunction
* Current treatment with medications that are well known to prolong the QT interval
* Active inflammatory bowel disease or chronic diarrhea, short bowel syndrome, or major upper gastrointestinal surgery including gastric resection
* Treatment with strong CYP3A4 inhibitors or inducers within 14 days or 5 drug elimination half-lives prior to randomization
* Known HIV infection
* Serious infection requiring oral or IV antibiotics, or other clinically significant infection within 14 days prior to screening
* Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/09/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/11/2021
Sample size
Target
Accrual to date
Final
221
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Macquarie University Hospital - Macquarie Park
Recruitment hospital [2] 0 0
Westmead Hospital; Medical Oncology and Pallative Care - Westmead
Recruitment postcode(s) [1] 0 0
2109 - Macquarie Park
Recruitment postcode(s) [2] 0 0
2145 - Westmead
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
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
New Jersey
Country [4] 0 0
United States of America
State/province [4] 0 0
Tennessee
Country [5] 0 0
United States of America
State/province [5] 0 0
Wisconsin
Country [6] 0 0
Brazil
State/province [6] 0 0
PE
Country [7] 0 0
Brazil
State/province [7] 0 0
RS
Country [8] 0 0
Brazil
State/province [8] 0 0
SP
Country [9] 0 0
Germany
State/province [9] 0 0
Dresden
Country [10] 0 0
Germany
State/province [10] 0 0
Düsseldorf
Country [11] 0 0
Germany
State/province [11] 0 0
Erlangen
Country [12] 0 0
Hungary
State/province [12] 0 0
Kecskemet
Country [13] 0 0
Hungary
State/province [13] 0 0
Szekszárd
Country [14] 0 0
Korea, Republic of
State/province [14] 0 0
Gyeonggi-do
Country [15] 0 0
Korea, Republic of
State/province [15] 0 0
Seoul
Country [16] 0 0
Poland
State/province [16] 0 0
Gdynia
Country [17] 0 0
Poland
State/province [17] 0 0
Lublin
Country [18] 0 0
Poland
State/province [18] 0 0
Warszawa
Country [19] 0 0
Poland
State/province [19] 0 0
Wroclaw
Country [20] 0 0
Russian Federation
State/province [20] 0 0
Moskovskaja Oblast
Country [21] 0 0
Russian Federation
State/province [21] 0 0
Sankt Petersburg
Country [22] 0 0
Russian Federation
State/province [22] 0 0
Tatarstan
Country [23] 0 0
Russian Federation
State/province [23] 0 0
Nizhny Novgorod
Country [24] 0 0
Russian Federation
State/province [24] 0 0
Saint-Petersburg
Country [25] 0 0
Russian Federation
State/province [25] 0 0
St. Petersburg
Country [26] 0 0
Spain
State/province [26] 0 0
Barcelona
Country [27] 0 0
Spain
State/province [27] 0 0
Cadiz
Country [28] 0 0
Spain
State/province [28] 0 0
Lerida
Country [29] 0 0
Spain
State/province [29] 0 0
Madrid
Country [30] 0 0
Spain
State/province [30] 0 0
Tarragona
Country [31] 0 0
Spain
State/province [31] 0 0
Tenerife
Country [32] 0 0
Spain
State/province [32] 0 0
Granada
Country [33] 0 0
Spain
State/province [33] 0 0
Lugo
Country [34] 0 0
Spain
State/province [34] 0 0
Murcia
Country [35] 0 0
Spain
State/province [35] 0 0
Navarra
Country [36] 0 0
Spain
State/province [36] 0 0
Sevilla
Country [37] 0 0
Spain
State/province [37] 0 0
Valencia
Country [38] 0 0
Taiwan
State/province [38] 0 0
Tainan
Country [39] 0 0
Taiwan
State/province [39] 0 0
Taipei
Country [40] 0 0
Ukraine
State/province [40] 0 0
Kharkiv Governorate
Country [41] 0 0
Ukraine
State/province [41] 0 0
Podolia Governorate
Country [42] 0 0
Ukraine
State/province [42] 0 0
Dnipropetrovsk
Country [43] 0 0
Ukraine
State/province [43] 0 0
Kryvyi Rih
Country [44] 0 0
Ukraine
State/province [44] 0 0
Kyiv

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 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 Sharing of Clinical Study 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/NCT04436744