Human Epidermal Growth Factor 2 Negative Carcinoma of Breast Clinical Trial
Official title:
Phase II Comparative Study of Myocet Plus Cyclophosphamide in First Line Treatment of HER2 Negative Metastatic Breast Patients
This is a phase II comparative randomized clinical trial.
Eligible patients will be randomized (1:1) to:
Arm A: Myocet plus Cyclofosfamide plus Metformin Arm B: Myocet plus Cyclofosfamide
Statistical Considerations:
In this randomized phase II study, the sample size was calculated basing on the primary
end-point (PFS) and assuming an error α = 10% (2-tailed) with a power of 80%.
To find an advantage of 4 months of median time to progression (6 months in the control arm
B and 10 months in the experimental arm A) will be recruited 112 patients (98 events) for a
period of 24 months and will be considered further 12-month of follow-up. The primary
analysis of the study will be conducted in accordance with the "intention to treat"
principle, the secondary analysis will be conducted in the "per protocol" population.
MULTICENTER, RANDOMIZED, COMPARATIVE STUDY OF MYOCET PLUS CYCLOPHOSPHAMIDE PLUS METFORMIN
VERSUS MYOCET PLUS CYCLOPHOSPHAMIDE IN FIRST LINE TREATMENT OF HER2 NEGATIVE METASTATIC
BREAST CANCER PATIENTS.
The aim of this study is to determine if the addition of metformin to the regime Myocet /
Cyclophosphamide improves disease-free survival in patients with HER2-negative metastatic
breast cancer.
The primary objective is the evaluation of the clinical efficacy of the combination of
Myocet / Cyclophosphamide plus Metformin compared to treatment with only Myocet /
Cyclophosphamide, in terms of progression-free survival (PFS).
Clinical secondary objectives are:
- Objective response rate
- Overall survival
- Tolerability
- Progression-free survival, objective response rate and overall survival according to
Homa Index levels.
Secondary biological endpoint is the characterization of the metabolic profile of patients
(sensitivity in insulin levels).
Treatment Arm A (experimental treatment):
Metformin 1000 mg, 2 times daily per os*. Myocet 60 mg/m2, intravenous infusion, on day 1,
every 21 days Cyclophosphamide 600 mg/m2, intravenous infusion, at day 1 every 21 days.
* During cycle 1, patients will assume only metformin from day 1 to day 13 and will begin
chemotherapy from day 14. From day 1 to day 3, patients will assume Metformin 1000 mg once a
day. Starting from day 4 patients will assume Metformin 1000 mg 2 times a day.
Arm B (standard treatment):
Myocet 60 mg/m2, intravenous infusion, on day 1, every 21 days Cyclophosphamide 600 mg/m2,
intravenous infusion, on day 1, every 21 days
Chemotherapy will be performed for 8 cycles.
The treatment will be continued until progression of disease.
Statistical Considerations:
In this randomized phase II study, the sample size was calculated basing on the primary
end-point (PFS) and assuming an error α = 10% (2-tailed) with a power of 80%.
To find an advantage of 4 months of median time to progression (6 months in the control arm
B and 10 months in the experimental arm A) will be recruited 112 patients (98 events) for a
period of 24 months and will be considered further 12-month of follow-up. The primary
analysis of the study will be conducted in accordance with the "intention to treat"
principle, the secondary analysis will be conducted in the "per protocol" population.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02894398 -
Study in Women With Advanced Breast Cancer Receiving Palbociclib With AI or Fulvestrant
|
Phase 2 | |
| Recruiting |
NCT02175446 -
Safety and Efficacy Study of Eribulin in Combination With Bevacizumab for Second-line Treatment HER2- MBC Patients
|
Phase 2 | |
| Terminated |
NCT01918306 -
GDC-0941 and Cisplatin in Treating Patients With Androgen Receptor-Negative Triple Negative Metastatic Breast Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT01935492 -
8 Continuous vs 8 Intermittent Cycles in First and Second Line in HER2/Neu Neg Metastatic Breast Cancer
|
Phase 3 | |
| Recruiting |
NCT05735080 -
Open-Label Study to Evaluate the Safety, Tolerability, PK, and Efficacy of INX-315 in Patients With Advanced Cancer
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT02668666 -
Palbociclib in Combination With Tamoxifen as First Line Therapy for Metastatic Hormone Receptor Positive Breast Cancer
|
Phase 2 | |
| Terminated |
NCT02823262 -
A Breast Cancer Treatment Decision Aid for Women Aged 70 and Older
|
N/A | |
| Completed |
NCT02806817 -
ME-344 in Early HER2-negative Breast Cancer With Antiangiogenic-induced Mitochondrial Metabolism
|
Early Phase 1 | |
| Terminated |
NCT02824575 -
Rebastinib Plus Antitubulin Therapy With Paclitaxel or Eribulin in Metastatic Breast Cancer
|
Phase 1 | |
| Terminated |
NCT01394211 -
Neo-adjuvant Therapy With Anastrozole Plus Pazopanib in Stage II and III ER+ Breast Cancer
|
Phase 2 | |
| Not yet recruiting |
NCT06338644 -
Palbociclib in Metastatic Breast Cancer: Gene Polymorphism-based Study in Egyptian Patients.
|
||
| Not yet recruiting |
NCT06348134 -
Assessing the Efficacy and Safety of Anti-HER2 Therapy in Nigerian Women With HER2+ Breast Cancer Before and After Surgery
|
Phase 2 | |
| Not yet recruiting |
NCT01779531 -
Compare the Outcomes of XT and XEC Adjuvant Chemotherapy in HER2-negative Luminal B Breast Cancer Patients
|
N/A | |
| Completed |
NCT01288261 -
Paclitaxel and Bavituximab in Treating Patients With HER2-Negative Metastatic Breast Cancer
|
Phase 1 | |
| Completed |
NCT03285568 -
Patterns of Prescribing and Monitoring of Palbociclib
|
||
| Active, not recruiting |
NCT02623972 -
A Phase 2 Study of Eribulin Followed by AC as Preoperative Therapy for HER2-negative Inflammatory Breast Cancer
|
Phase 2 | |
| Terminated |
NCT01905592 -
A Phase III Trial of Niraparib Versus Physician's Choice in HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients
|
Phase 3 | |
| Recruiting |
NCT06264921 -
A Study With NKT3447 for Adults With Advanced/Metastatic Solid Tumors
|
Phase 1 | |
| Not yet recruiting |
NCT03854617 -
A Study to Evaluate the Efficacy and Safety of Oral Navelbine in Female Patients With HER2-Negative Metastatic Breast Cancer
|
Phase 2 | |
| Recruiting |
NCT02404051 -
Fulvestrant and EVerolimus Plus EXemestane in Metastatic Breast Cancer
|
Phase 3 |