Metastatic Breast Cancer Clinical Trial
Official title:
A Phase II Non-randomized, Parallel Group Study of Goserelin or Leuprorelin Plus Letrozole in Premenopausal Patients Versus Letrozole Alone in Postmenopausal Patients With Metastatic Breast Cancer
Verified date | September 2007 |
Source | National Cancer Center, Korea |
Contact | n/a |
Is FDA regulated | No |
Health authority | South Korea: Institutional Review Board |
Study type | Interventional |
Primary objective is to evaluate the response rates and clinical benefits of letrozole + goserelin in premenopausal patients versus letrozole alone in postmenopausal patients with metastatic breast cancer as first line hormonal therapy
Status | Completed |
Enrollment | 78 |
Est. completion date | August 2010 |
Est. primary completion date | April 2008 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Histologically or cytologically diagnosed stage IV or recurrent breast cancer patients according to American Joint Committee on Cancer (AJCC) 2. Positive estrogen receptor or progesterone receptor (>grade 3/7 by modified Allred IHC score) 3. Females at least 18 years of age and under 75 years 4. Prior chemotherapy for adjuvant setting or metastatic disease is allowed if the number of chemotherapy is = 3. 5. Prior adjuvant antiestrogen therapy is allowed, provided that had not been received within 3 weeks before the entry of the study 6. Prior adjuvant aromatase inhibitor therapy is allowed if the agent had not been given within one year of the entry. 7. Prior radiation therapy is allowed as long as the irradiated area is not the only source of measurable disease. 8. No other forms of cancer therapy, such as radiation, immunotherapy for at least 3 weeks before the enrollment in the study. 9. Performance status of 0, 1 and 2 on the ECOG criteria. 10. Clinically measurable disease, defined as unidimensionally measurable lesions with clearly defined margins on x-ray, CT scan, MRI or physical examination. Lesions serving as measurable disease must be at least 1 cm by 1 cm, as defined by x-ray, CT scan, MRI, or physical examination. 11. Bone only or pleural fluid only disease is included as long as evaluation for clinical benefit is possible. 12. Estimated life expectancy of at least 12 weeks. 13. Compliant patient who can be followed-up adequately. 14. Adequate hematologic (WBC count 3,000/mm3, platelet count 100,000/mm3), hepatic (bilirubin level 1.8 mg/dL, AST, ALT 2.0xULN, albumin 2.5 g/dL), and renal (creatinine concentration 1.5 mg/dL) function. 15. Informed consent from patient or patient's relative. 16. Childbearing women should use non-hormonal contraceptive method. Exclusion Criteria: 1. Previous chemotherapy more than 3 including adjuvant therapy. 2. Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence). |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | National Cancer Center | Goyang |
Lead Sponsor | Collaborator |
---|---|
National Cancer Center, Korea |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate the response rates and clinical benefits of letrozole + goserelin in premenopausal patients versus letrozole alone in postmenopausal patients with metastatic breast cancer as first line hormonal therapy | 4 years | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT04872608 -
A Study of Letrozole, Palbociclib, and Onapristone ER in People With Metastatic Breast Cancer
|
Phase 1 | |
Terminated |
NCT02202746 -
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
|
Phase 2 | |
Completed |
NCT02506556 -
Phosphatidylinositol 3-kinase (PI3K) Alpha iNhibition In Advanced Breast Cancer
|
Phase 2 | |
Recruiting |
NCT05534438 -
A Study on Adding Precisely Targeted Radiation Therapy (Stereotactic Body Radiation Therapy) to the Usual Treatment Approach (Drug Therapy) in People With Breast Cancer
|
Phase 2 | |
Recruiting |
NCT03368729 -
Niraparib in Combination With Trastuzumab in Metastatic HER2+ Breast Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT04103853 -
Safety, Tolerability, and Pharmacokinetics of Proxalutamide Therapy in Women With Metastatic Breast Cancer
|
Phase 1 | |
Terminated |
NCT01847599 -
Educational Intervention to Adherence of Patients Treated by Capecitabine +/- Lapatinib
|
N/A | |
Active, not recruiting |
NCT03147287 -
Palbociclib After CDK and Endocrine Therapy (PACE)
|
Phase 2 | |
Not yet recruiting |
NCT06062498 -
Elacestrant vs Elacestrant Plus a CDK4/6 Inhibitor in Patients With ERpositive/HER2-negative Advanced or Metastatic Breast Cancer
|
Phase 2 | |
Recruiting |
NCT05383196 -
Onvansertib + Paclitaxel In TNBC
|
Phase 1/Phase 2 | |
Recruiting |
NCT04095390 -
A Phase Ⅱ Trial of Pyrotinib Combination With CDK4/6 Inhibitor SHR6390 in Patients Prior Trastuzumab-treated Advanced HER2-Positive Breast Cancer
|
Phase 2 | |
Active, not recruiting |
NCT04432454 -
Evaluation of Lasofoxifene Combined With Abemaciclib in Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation
|
Phase 2 | |
Recruiting |
NCT03323346 -
Phase II Trial of Disulfiram With Copper in Metastatic Breast Cancer
|
Phase 2 | |
Recruiting |
NCT05744375 -
Trastuzumab Deruxtecan in First-line HER2-positive Locally Advanced/MBC Patients Resistant to Trastuzumab+Pertuzumab
|
Phase 2 | |
Completed |
NCT02924883 -
A Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Atezolizumab-Placebo in Participants With Human Epidermal Growth Factor-2 (HER2) Positive Locally Advanced or Metastatic Breast Cancer (BC) Who Received Prior Trastuzumab and Taxane Based Therapy
|
Phase 2 | |
Completed |
NCT01942135 -
Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)
|
Phase 3 | |
Completed |
NCT01881230 -
Evaluate Risk/Benefit of Nab Paclitaxel in Combination With Gemcitabine and Carboplatin Compared to Gemcitabine and Carboplatin in Triple Negative Metastatic Breast Cancer (or Metastatic Triple Negative Breast Cancer)
|
Phase 2/Phase 3 | |
Active, not recruiting |
NCT04448886 -
Sacituzumab Govitecan +/- Pembrolizumab In HR+ / HER2 - MBC
|
Phase 2 | |
Completed |
NCT01401959 -
Trial of Eribulin in Patients Who Do Not Achieve Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy
|
Phase 2 | |
Terminated |
NCT04720664 -
Oral SM-88 in Patients With Metastatic HR+/HER2- Breast Cancer
|
Phase 2 |