Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2015-000106-19 | EudraCT Number |
Not provided
Not provided
The Sponsor decided to halt the development of GDC-0810, but not due to any safety concerns.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of GDC-0810 compared with fulvestrant in postmenopausal women with advanced or metastatic estrogen receptor positive (ER+)/ human epidermal growth factor receptor 2 negative (HER2-) breast cancer resistant to AI therapy. The development of GDC-0810 has been halted by the Sponsor and the enrollment in this study has been discontinued. Participants currently enrolled in the study who are experiencing clinical benefit may continue receiving GDC-0810 as a single agent or fulvestrant until disease progression (PD), unmanageable toxicity, withdrawal of consent, exhaustion of GDC-0810 drug supply, or termination of the study by the Sponsor.
Not provided
Not provided
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fulvestrant | Active Comparator | Participants will receive 500 milligrams (mg) of fulvestrant as two intramuscular injections (250 mg each) on Day 1 and Day 15 of Cycle 1, and on Day 1 of each subsequent 28-day cycle until disease progression, unmanageable toxicity, withdrawal of consent, exhaustion of GDC-0810 drug supply, or termination of study by the Sponsor. |
|
| GDC-0810 | Experimental | Participants will receive three 200 mg tablets (total dose = 600 mg) of GDC-0810 orally once daily until disease progression, unmanageable toxicity, withdrawal of consent, exhaustion of GDC-0810 drug supply, or termination of study by the Sponsor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fulvestrant | Drug | Fulvestrant at a dose of 500 mg as two intramuscular injections will be administered on Day 1 and Day 15 of Cycle 1, and on Day 1 of each subsequent 28-day cycle. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in Intent-to-Treat (ITT) Population | PFS was defined as the time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments using RECIST v1.1 or death on study from any cause. | From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 25 months) |
| PFS According to RECIST v1.1 in Participants With Estrogen Receptor (ESR)1 Mutations | PFS was defined as the time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments using RECIST v1.1 or death on study from any cause. | From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 25 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS is defined as the time from randomization to death from any cause. | From Day 1 to death from any cause, assessed up to end of study (up to approximately 25 months) |
| Percentage of Participants With Objective Response (Partial Response [PR] Plus Complete Response [CR]) According to RECIST v1.1 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Cancer Center | New Haven | Connecticut | 06520 | United States | ||
| Florida Cancer Specialists-Broadway, Fort Myers |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | GDC-0810 | Participants will receive three 200 mg tablets (total dose = 600 mg) of GDC-0810 orally once daily until disease progression, unmanageable toxicity, withdrawal of consent, exhaustion of GDC-0810 drug supply, or termination of study by the Sponsor. |
| FG001 | Fulvestrant |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 24, 2017 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| GDC-0810 | Drug | GDC-0810 will be administered as tablets at a dose of 600 mg orally once daily. |
|
|
Objective Response was defined as the percentage of participants who attained CR or PR. CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm, PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. |
| From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 25 months) |
| Duration of Response (DOR) Assessed Using RECIST v1.1 | DOR was defined as the time from first observation of an objective response until first observation of disease progression as assessed by the investigator according to RECIST v1.1 or death from any cause. | From objective response to PD or death from any cause, assessed up to end of study (up to approximately 25 months) |
| Percentage of Participants With Clinical Benefit (PR, CR, or Stable Disease, Lasting for At Least 24 Weeks) Assessed Using RECIST v1.1 | From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 25 months) |
| Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | From Day 1 to 28 days after last dose of study drug, assessed up to end of study (up to approximately 25 months) |
| GDC-0810 Plasma Concentrations by Visit | Concentration of GDC-0810 measured in plasma after a single dose (Cycle 1 Day 1) and at steady state (Cycle 3 Day 1) | Predose (within 30 minutes of GDC-0810 administration) and 3 hours postdose on Day 1 of Cycles 1 and 3; Cycle length=28 days |
| Fort Myers |
| Florida |
| 33908 |
| United States |
| Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building) | St. Petersburg | Florida | 33705 | United States |
| Oncology Hematology Care Inc | Cincinnati | Ohio | 45242 | United States |
| Tennessee Oncology PLLC | Franklin | Tennessee | 37067 | United States |
| The Center for Cancer and Blood Disorders - Fort Worth | Fort Worth | Texas | 76104 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| St Vincent's Hospital Sydney | Darlinghurst | New South Wales | 2010 | Australia |
| Port Macquarie Base Hospital | Port Macquarie | New South Wales | 2444 | Australia |
| Adelaide Cancer Centre | Kurralta Park | South Australia | 5037 | Australia |
| Royal Hobart Hospital; Medical Oncology | Hobart | Tasmania | 7000 | Australia |
| Footscray Hospital | Footscray | Victoria | 3011 | Australia |
| Peninsula and South Eastern Haematology and Oncology Group | Frankston | Victoria | 3199 | Australia |
| Epworth HealthCare; Clinical Trials Centre | Richmond | Victoria | 3121 | Australia |
| Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden | Dresden | 01307 | Germany |
| Universitätsklinikum Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| Praxisklinik für Hämatologie und Onkologie Dres. Köppler/Heymans/Weide/Thomalla | Koblenz | 56068 | Germany |
| HELIOS Klinikum Krefeld; Klinik für Frauenheilkunde und Geburtshilfe | Krefeld | 47805 | Germany |
| Rotkreuzklinikum München; Frauenklinik | München | 80637 | Germany |
| Universitätsklinikum Tübingen | Tübingen | 72076 | Germany |
| Marien Hospital Witten Gemeinnützige GmbH | Witten | 58452 | Germany |
| Kyungpook National University Medical Center | Daegu | 41404 | South Korea |
| National Cancer Center | Goyang-si | 10408 | South Korea |
| Samsung Medical Center | Seoul | (0)6351 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Korea University Guro Hospital | Seoul | 08308 | South Korea |
| Ulsan University Hosiptal | Ulsan | 44033 | South Korea |
| Hospital Clinic | Barcelona | Cantabria | 08036 | Spain |
| Complejo Hospitalario Universitario A Coruña; Servicio de Endocrinologia | A Coruña | LA Coruña | 15006 | Spain |
| Hospital Universitari Arnau de Vilanova | Lleida | Lerida | 25198 | Spain |
| Hospital del Mar | Barcelona | 08003 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital General Universitario Gregorio Marañon | Madrid | 28007 | Spain |
| Hospital Universitario Ramon y Cajal | Madrid | 28034 | Spain |
| Hosp. Clinico San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| Royal Sussex County Hospital | Brighton | BN2 5BE | United Kingdom |
| Western General Hospital | Edinburgh | EH4 2XU | United Kingdom |
| St Bartholomew's Hospital | London | EC1A 7BE | United Kingdom |
| University College Hospital | London | N7 9NH | United Kingdom |
| Sarah Cannon Research Institute | London | W1G 6AD | United Kingdom |
| Macclesfield District General Hospital | Macclesfield | SK10 3BL | United Kingdom |
| Nottingham City Hospital | Nottingham | NG5 1PB | United Kingdom |
Participants will receive 500 milligrams (mg) of fulvestrant as two intramuscular injections (250 mg each) on Day 1 and Day 15 of Cycle 1, and on Day 1 of each subsequent 28-day cycle until disease progression, unmanageable toxicity, withdrawal of consent, exhaustion of GDC-0810 drug supply, or termination of study by the Sponsor. |
|
| Received Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | GDC-0810 | Participants will receive three 200 mg tablets (total dose = 600 mg) of GDC-0810 orally once daily until disease progression, unmanageable toxicity, withdrawal of consent, exhaustion of GDC-0810 drug supply, or termination of study by the Sponsor. |
| BG001 | Fulvestrant | Participants will receive 500 milligrams (mg) of fulvestrant as two intramuscular injections (250 mg each) on Day 1 and Day 15 of Cycle 1, and on Day 1 of each subsequent 28-day cycle until disease progression, unmanageable toxicity, withdrawal of consent, exhaustion of GDC-0810 drug supply, or termination of study by the Sponsor. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in Intent-to-Treat (ITT) Population | PFS was defined as the time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments using RECIST v1.1 or death on study from any cause. | Outcome Measures not assessed based on pre-specified thresholds not having been met. | Posted | From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 25 months) |
|
| ||||||||||||||||||||||
| Primary | PFS According to RECIST v1.1 in Participants With Estrogen Receptor (ESR)1 Mutations | PFS was defined as the time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments using RECIST v1.1 or death on study from any cause. | Outcome Measures not assessed based on pre-specified thresholds not having been met. | Posted | From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 25 months) |
|
| ||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS is defined as the time from randomization to death from any cause. | Outcome Measures not assessed based on pre-specified thresholds not having been met. | Posted | From Day 1 to death from any cause, assessed up to end of study (up to approximately 25 months) |
|
| ||||||||||||||||||||||
| Secondary | Percentage of Participants With Objective Response (Partial Response [PR] Plus Complete Response [CR]) According to RECIST v1.1 | Objective Response was defined as the percentage of participants who attained CR or PR. CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm, PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. | Posted | Number | 90% Confidence Interval | percentage | From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 25 months) |
| |||||||||||||||||||||
| Secondary | Duration of Response (DOR) Assessed Using RECIST v1.1 | DOR was defined as the time from first observation of an objective response until first observation of disease progression as assessed by the investigator according to RECIST v1.1 or death from any cause. | Outcome Measures not assessed based on pre-specified thresholds not having been met. | Posted | From objective response to PD or death from any cause, assessed up to end of study (up to approximately 25 months) |
|
| ||||||||||||||||||||||
| Secondary | Percentage of Participants With Clinical Benefit (PR, CR, or Stable Disease, Lasting for At Least 24 Weeks) Assessed Using RECIST v1.1 | Posted | Number | 90% Confidence Interval | percentage of participants | From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 25 months) |
|
| |||||||||||||||||||||
| Secondary | Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | Participants who received at least one dose of any study drug | Posted | Number | percentage of participants | From Day 1 to 28 days after last dose of study drug, assessed up to end of study (up to approximately 25 months) |
|
| |||||||||||||||||||||
| Secondary | GDC-0810 Plasma Concentrations by Visit | Concentration of GDC-0810 measured in plasma after a single dose (Cycle 1 Day 1) and at steady state (Cycle 3 Day 1) | Participants who received at least one dose of any study drug and provided a post-dose blood sample in the GDC-0810 arm | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter (ng/mL) | Predose (within 30 minutes of GDC-0810 administration) and 3 hours postdose on Day 1 of Cycles 1 and 3; Cycle length=28 days |
|
|
Up to approximately 25 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GDC-0810 | Participants will receive three 200 mg tablets (total dose = 600 mg) of GDC-0810 orally once daily until disease progression, unmanageable toxicity, withdrawal of consent, exhaustion of GDC-0810 drug supply, or termination of study by the Sponsor. | 12 | 35 | 7 | 35 | 33 | 35 |
| EG001 | Fulvestrant | Participants will receive 500 milligrams (mg) of fulvestrant as two intramuscular injections (250 mg each) on Day 1 and Day 15 of Cycle 1, and on Day 1 of each subsequent 28-day cycle until disease progression, unmanageable toxicity, withdrawal of consent, exhaustion of GDC-0810 drug supply, or termination of study by the Sponsor. | 4 | 35 | 5 | 35 | 31 | 35 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CARDIAC TAMPONADE | Cardiac disorders | MedDRA version 22.1. | Non-systematic Assessment |
| |
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA version 22.1. | Non-systematic Assessment |
| |
| GASTRITIS HAEMORRHAGIC | Gastrointestinal disorders | MedDRA version 22.1. | Non-systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA version 22.1. | Non-systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA version 22.1. | Non-systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA version 22.1. | Non-systematic Assessment |
| |
| FEMORAL NECK FRACTURE | Injury, poisoning and procedural complications | MedDRA version 22.1. | Non-systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA version 22.1. | Non-systematic Assessment |
| |
| BRACHIAL PLEXOPATHY | Nervous system disorders | MedDRA version 22.1. | Non-systematic Assessment |
| |
| URINARY TRACT OBSTRUCTION | Renal and urinary disorders | MedDRA version 22.1. | Non-systematic Assessment |
| |
| ASPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.1. | Non-systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.1. | Non-systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA version 22.1. | Non-systematic Assessment |
| |
| LYMPHOEDEMA | Vascular disorders | MedDRA version 22.1. | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA version 22.1. | Non-systematic Assessment |
| |
| PALPITATIONS | Cardiac disorders | MedDRA version 22.1. | Non-systematic Assessment |
| |
| ABDOMINAL DISCOMFORT | Gastrointestinal disorders | MedDRA version 22.1. | Non-systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA version 22.1. | Non-systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA version 22.1. | Non-systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA version 22.1. | Non-systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA version 22.1. | Non-systematic Assessment |
| |
| DRY MOUTH | Gastrointestinal disorders | MedDRA version 22.1. | Non-systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA version 22.1. | Non-systematic Assessment |
| |
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA version 22.1. | Non-systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA version 22.1. | Non-systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA version 22.1. | Non-systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA version 22.1. | Non-systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA version 22.1. | Non-systematic Assessment |
| |
| INJECTION SITE PAIN | General disorders | MedDRA version 22.1. | Non-systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA version 22.1. | Non-systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA version 22.1. | Non-systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA version 22.1. | Non-systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA version 22.1. | Non-systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA version 22.1. | Non-systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA version 22.1. | Non-systematic Assessment |
| |
| HYPOALBUMINAEMIA | Metabolism and nutrition disorders | MedDRA version 22.1. | Non-systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA version 22.1. | Non-systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA version 22.1. | Non-systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA version 22.1. | Non-systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA version 22.1. | Non-systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA version 22.1. | Non-systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA version 22.1. | Non-systematic Assessment |
| |
| MUSCULOSKELETAL STIFFNESS | Musculoskeletal and connective tissue disorders | MedDRA version 22.1. | Non-systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA version 22.1. | Non-systematic Assessment |
| |
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA version 22.1. | Non-systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA version 22.1. | Non-systematic Assessment |
| |
| BALANCE DISORDER | Nervous system disorders | MedDRA version 22.1. | Non-systematic Assessment |
| |
| DISTURBANCE IN ATTENTION | Nervous system disorders | MedDRA version 22.1. | Non-systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA version 22.1. | Non-systematic Assessment |
| |
| DYSGEUSIA | Nervous system disorders | MedDRA version 22.1. | Non-systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA version 22.1. | Non-systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA version 22.1. | Non-systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA version 22.1. | Non-systematic Assessment |
| |
| POLLAKIURIA | Renal and urinary disorders | MedDRA version 22.1. | Non-systematic Assessment |
| |
| BREAST PAIN | Reproductive system and breast disorders | MedDRA version 22.1. | Non-systematic Assessment |
| |
| VAGINAL DISCHARGE | Reproductive system and breast disorders | MedDRA version 22.1. | Non-systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.1. | Non-systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.1. | Non-systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.1. | Non-systematic Assessment |
| |
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA version 22.1. | Non-systematic Assessment |
| |
| HOT FLUSH | Vascular disorders | MedDRA version 22.1. | Non-systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA version 22.1. | Non-systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| Feb 5, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077267 | Fulvestrant |
| C000606997 | 3-(4-(2-(2-chloro-4-fluorophenyl)-1-(1H-indazol-5-yl)but-1-en-1-yl)phenyl)acrylic acid |
| ID | Term |
|---|---|
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
|
|