Advanced Breast Cancer Clinical Trial
Official title:
A Double Blind, Double Dummy, Randomised, Multicentre Study to Compare the Efficacy and Safety of Fulvestrant 250mg With Arimidex 1mg as a Secondary-line Therapy in the Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer
| Verified date | January 2011 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | China: Food and Drug Administration |
| Study type | Interventional |
This study will evaluate the efficacy and safety of Faslodex as secondary-line treatment compared with Arimidex in oestrogen receptor positive postmenopausal advanced breast cancer.
| Status | Completed |
| Enrollment | 234 |
| Est. completion date | September 2007 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Postmenopausal advanced breast cancer with oestrogen receptor positive - Progression under first-line anti-oestrogen therapy. Exclusion Criteria: - Life-threatening metastasis; contraindication to anastrozole - >2 regimens of hormonotherapy for advanced breast cancer |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| China | Research Site | Beijing | |
| China | Research Site | Dalian | |
| China | Research Site | Fuzhou | |
| China | Research Site | Guangzhou | |
| China | Research Site | Hankou | |
| China | Research Site | He Fei | |
| China | Research Site | Huangzhou | |
| China | Research Site | Ji Nan | |
| China | Research Site | Nanjing | |
| China | Research Site | Shanghai | |
| China | Research Site | Wuhan | |
| China | Research Site | Xi AN |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time to Disease Progression (TTP) | |||
| Secondary | Objective Response Rate (ORR) | |||
| Secondary | Clinical Benefit Rate (CBR) | |||
| Secondary | Time to Treatment Failure (TTF) | |||
| Secondary | Safety & Tolerability. |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04653740 -
Omic Technologies to Track Resistance to Palbociclib in Metastatic Breast Cancer
|
N/A | |
| Recruiting |
NCT05156619 -
Health Care Disparities in Culturally Diverse, Special Needs & Disadvantaged Populations - Bridging the Gap
|
||
| Recruiting |
NCT05173103 -
Retrospective Study of 2nd-line Therapies After CDK4/6i + Hormonal Therapy in HR+/HER2- Advanced Breast Cancer
|
||
| Withdrawn |
NCT05191004 -
Study of NUV-422 in Combination With Fulvestrant in Patients With HR+HER2- aBC
|
Phase 1/Phase 2 | |
| Completed |
NCT00754325 -
Randomized Trial of Fulvestrant With or Without Dasatinib in Men and Postmenopausal Women Who Have Hormone Receptor-positive Advanced Breast Cancer Previously Treated With an Aromatase Inhibitor
|
Phase 2 | |
| Recruiting |
NCT04953377 -
PFMT Educational Intervention for Patients With Advancer Breast Cancer
|
N/A | |
| Completed |
NCT03240224 -
Bioinformation Therapy for Breast Cancer
|
Phase 2/Phase 3 | |
| Recruiting |
NCT06193525 -
FUnctional Selection of Advanced Breast Cancer Patients for Talazoparib Treatment Using the REpair Capacity (RECAP) Test
|
Phase 2 | |
| Completed |
NCT03312738 -
A Study of Everolimus Plus Exemestane in Chinese Postmenopausal Women With Estrogen Receptor Positive, Locally Advanced, Recurrent, or Metastatic Breast Cancer After Recurrence or Progression on Non-steroidal Aromatase Inhibitor
|
Phase 2 | |
| Active, not recruiting |
NCT05063786 -
Trastuzumab + Alpelisib +/- Fulvestrant vs Trastuzumab + CT in Patients With PIK3CA Mutated Previously Treated HER2+ Advanced BrEasT Cancer (ALPHABET)
|
Phase 3 | |
| Recruiting |
NCT05655598 -
TAS-116 Plus Palbociclib in Breast and Rb-null Cancer
|
Phase 1 | |
| Active, not recruiting |
NCT02499146 -
Palbociclib Pharmacokinetics Study In Postmenopausal Chinese Women With ER (+), HER2 (-) Advanced Breast Cancer
|
Phase 1 | |
| Completed |
NCT00445458 -
A Phase 1/2 Study of HKI-272 (Neratinib) in Combination With Paclitaxel (Taxol) in Subjects With Solid Tumors and Breast Cancer
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04456855 -
Locoregional Surgery of the Primary Tumor in de Novo Stage IV Breast Cancer Patients
|
||
| Completed |
NCT04408118 -
First Line Atezolizumab, Paclitaxel, and Bevacizumab (Avastin®) in mTNBC
|
Phase 2 | |
| Recruiting |
NCT04222413 -
Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors
|
Phase 1 | |
| Completed |
NCT03205761 -
Analysis of Olaparib Response in Patients With BRCA1 and/or 2 Promoter Methylation Diagnosed of Advanced Breast Cancer
|
Phase 2 | |
| Withdrawn |
NCT04316169 -
Hydroxychloroquine, Abemaciclib and Endocrine Therapy in Hormone Receptor Positive (HR+)/Her 2 Negative Breast Cancer
|
Phase 1 | |
| Completed |
NCT00546104 -
Phase II Dasatinib Study in Advanced Breast Cancer
|
Phase 2 | |
| Completed |
NCT00387907 -
Study of Larotaxel in Combination With Weekly Herceptin® in Patients With HER2 Positive Metastatic Breast Cancer
|
Phase 2 |