A Study of Giredestrant (GDC-9545) in Postmenopausal Women With Stage I-III Operable, Estrogen Receptor-Positive Breast Cancer
NCT ID: NCT03916744
Last Updated: 2023-03-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
75 participants
INTERVENTIONAL
2019-07-26
2021-05-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Giredestrant 10 mg
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).
Surgery
Breast cancer surgery will take place on Day 15 (+/-2 days).
Giredestrant 30 mg
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).
Surgery
Breast cancer surgery will take place on Day 15 (+/-2 days).
Giredestrant 100 mg
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).
Surgery
Breast cancer surgery will take place on Day 15 (+/-2 days).
Interventions
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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).
Surgery
Breast cancer surgery will take place on Day 15 (+/-2 days).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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University of Colorado
Aurora, Colorado, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
Sunshine Hospital
St Albans, Victoria, Australia
Clinique Edith Cavell; Pharmacie
Auderghem, , Belgium
UZ Antwerpen
Edegem, , Belgium
Clinique Sainte-Elisabeth; Oncologie
Namur, , Belgium
Onkologikoa - Instituto Oncológico de Donostia
Donostia / San Sebastian, Guipuzcoa, Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Ruber Internacional;Servicio de Oncologia
Madrid, , Spain
HM Sanchinarro ? CIOCC
Madrid, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Barts Health NHS Trust; William Harvey Heart Centre, QMUL School of Medicine & Dentistry
London, , United Kingdom
Royal Cornwall Hospital
Truro, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2018-003798-85
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GO40987
Identifier Type: -
Identifier Source: org_study_id
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