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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03916744




Registration number
NCT03916744
Ethics application status
Date submitted
10/04/2019
Date registered
16/04/2019

Titles & IDs
Public title
A Study of Giredestrant (GDC-9545) in Postmenopausal Women With Stage I-III Operable, Estrogen Receptor-Positive Breast Cancer
Scientific title
A Phase I, Multicenter, Open-Label Preoperative, Short-Term Window Study of GDC-9545 in Postmenopausal Women With Stage I-III Operable, Estrogen Receptor-Positive Breast Cancer
Secondary ID [1] 0 0
2018-003798-85
Secondary ID [2] 0 0
GO40987
Universal Trial Number (UTN)
Trial acronym
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 - Giredestrant
Treatment: Surgery - Surgery

Experimental: Giredestrant 10 mg -

Experimental: Giredestrant 30 mg -

Experimental: Giredestrant 100 mg -


Treatment: Drugs: Giredestrant
Giredestrant will be administered orally once daily (QD) starting on Day 1 up to and including the day of surgery (if allowed per local process) on Day 15 (+/-2 days).

Treatment: Surgery: Surgery
Breast cancer surgery will take place on Day 15 (+/-2 days).
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
Change From Baseline in Tumor Cell Proliferation, as Measured by the Proportion of Nuclei Staining Ki67-Positive at Surgery Relative to Baseline in Pre- and Post-Treatment Tumor Biopsy Samples
Timepoint [1] 0 0
Baseline and Surgery (Day 15)
Primary outcome [2] 0 0
Change From Baseline in Tumor Cell Proliferation, as Measured by the Difference in the Percentage of Nuclei Staining Ki67-Positive at Surgery Compared With Baseline in Pre- and Post-Treatment Tumor Biopsy Samples
Timepoint [2] 0 0
Baseline and Surgery (Day 15)
Secondary outcome [1] 0 0
Number of Participants With at Least One Adverse Event and by Severity, Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0)
Timepoint [1] 0 0
From Baseline to Day 43
Secondary outcome [2] 0 0
Percentage of Participants With Abnormal Vital Signs During Treatment
Timepoint [2] 0 0
Baseline, Days 1, 8, and 15
Secondary outcome [3] 0 0
Change From Baseline in Pulse Rate
Timepoint [3] 0 0
Baseline, Day 8, Surgery (Day 15), and Post-Surgery (Day 43)
Secondary outcome [4] 0 0
Change From Baseline in Systolic Blood Pressure
Timepoint [4] 0 0
Baseline, Day 8, Surgery (Day 15), and Post-Surgery (Day 43)
Secondary outcome [5] 0 0
Change From Baseline in Diastolic Blood Pressure
Timepoint [5] 0 0
Baseline, Day 8, Surgery (Day 15), and Post-Surgery (Day 43)
Secondary outcome [6] 0 0
Change From Baseline in Body Temperature
Timepoint [6] 0 0
Baseline, Day 8, Surgery (Day 15), and Post-Surgery (Day 43)
Secondary outcome [7] 0 0
Percentage of Participants With Laboratory Abnormalities in Hematology Tests During Treatment, Among Participants Without the Abnormality at Baseline
Timepoint [7] 0 0
Baseline, Days 1, 8, and 15
Secondary outcome [8] 0 0
Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline
Timepoint [8] 0 0
Baseline, Days 1, 8, and 15
Secondary outcome [9] 0 0
Percentage of Participants With Abnormal Electrocardiogram Parameters During Treatment
Timepoint [9] 0 0
Baseline, Days 1, 8, and 15
Secondary outcome [10] 0 0
Plasma Concentration of Giredestrant at Steady State by Dose Level
Timepoint [10] 0 0
Predose on day of surgery (Day 15), or prior to biopsy (Day 14)

Eligibility
Key inclusion criteria
* Ability to comply with the study protocol, in the investigator's judgment
* Histologically confirmed invasive breast carcinoma, with all of the following characteristics: Primary tumor greater than or equal to (=)1.5 centimeters (cm) in largest diameter by ultrasound; Stage I-III operable breast cancer; Documentation confirming the absence of distant metastasis (M0) as determined by institutional practice.
* ER-positive tumor and HER2-negative breast cancer as per local laboratory testing
* Postmenopausal status
* Breast cancer eligible for primary surgery
* Submission of a representative tumor tissue specimen
* Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to (=)1
* Adequate organ function
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Diagnosis of inflammatory breast cancer
* Diagnosis of bilateral breast cancer
* Concurrent use of hormone replacement therapies
* Previous systemic or local treatment for the primary breast cancer currently under investigation
* Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days prior to study entry
* Current treatment with any systemic anti-cancer therapies
* Major surgery within 4 weeks prior to enrollment
* Radiation therapy within 2 weeks prior to enrollment
* Diagnosis of any secondary malignancy within 3 years prior to enrollment, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer
* Active inflammatory bowel disease or chronic diarrhea, short bowel syndrome, or upper gastrointestinal surgery including gastric resection
* Known HIV infection
* Known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including active viral or other hepatitis, current alcohol abuse, or cirrhosis
* 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 giredestrant or any of its excipients
* Any condition requiring anti-coagulants, such as warfarin, heparin, or thrombolytic drugs
* History of documented hemorrhagic diathesis or coagulopathy
* History or presence of symptomatic bradycardia or sick sinus syndrome
* Baseline heart rate =55 beats per minute (bpm) prior to enrollment
* History or presence of an abnormal electrocardiogram (ECG) that is clinically significant in the investigator's opinion, including complete left bundle branch block, second- or third-degree heart block, or evidence of prior myocardial infarction
* QT interval corrected through use of Fridericia's formula (QTcF) >470 milliseconds demonstrated by at least two ECGs >30 minutes apart
* History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias such as structural heart disease, coronary heart disease, clinically significant electrolyte abnormalities, or family history of sudden unexplained death or long QT syndrome
* Current treatment with medications that are well known to prolong the QT interval
* History or presence of uncontrolled hypothyroidism
* Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications

Study design
Purpose of the study
Other
Allocation to intervention
Non-randomised 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 1
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
26/07/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/05/2021
Sample size
Target
Accrual to date
Final
75
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
St Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [2] 0 0
Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
3021 - St Albans
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
Belgium
State/province [4] 0 0
Auderghem
Country [5] 0 0
Belgium
State/province [5] 0 0
Edegem
Country [6] 0 0
Belgium
State/province [6] 0 0
Namur
Country [7] 0 0
Spain
State/province [7] 0 0
Guipuzcoa
Country [8] 0 0
Spain
State/province [8] 0 0
Barcelona
Country [9] 0 0
Spain
State/province [9] 0 0
Madrid
Country [10] 0 0
Spain
State/province [10] 0 0
Valencia
Country [11] 0 0
United Kingdom
State/province [11] 0 0
London
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Truro

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Genentech, Inc.
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)?
No
No/undecided IPD sharing reason/comment
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).


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/NCT03916744