Anatomic Stage III Breast Cancer AJCC v8 Clinical Trial
Official title:
Dose Reduction of Docetaxel-Based Chemotherapy in Vulnerable Older Women With Early-Stage Breast Cancer (DOROTHY)
This phase II trial tests how well dose-reduced docetaxel combined with cyclophosphamide works in treating older women with early stage (stage I-III) HER2 negative breast cancer vulnerable to toxicity. Chemotherapy drugs, such as docetaxel and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Docetaxel and cyclophosphamide are commonly used, but is not well tolerated at the standard dose and can affect the way older patients feel physically and emotionally. Giving dose-reduced docetaxel combined with cyclophosphamide may be an effective treatment option and improve quality of life in vulnerable older women with stage I-III HER2 negative breast cancer.
PRIMARY OBJECTIVE: I. Compare the relative dose intensity (RDI) of reduced- versus (vs.) standard-dose docetaxel dosing strategies. SECONDARY OBJECTIVE: I. Compare treatment tolerability of reduced- vs. standard-dose docetaxel dosing strategies. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive dose-reduced docetaxel intravenously (IV) over 60 minutes and cyclophosphamide IV over 30 minutes on day 1 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive standard dose docetaxel IV over 60 minutes and cyclophosphamide IV over 30 minutes on day 1 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days then at least twice yearly for 2 years. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Suspended |
NCT05673200 -
Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer
|
Phase 1 | |
Active, not recruiting |
NCT03218826 -
PI3Kbeta Inhibitor AZD8186 and Docetaxel in Treating Patients Advanced Solid Tumors With PTEN or PIK3CB Mutations That Are Metastatic or Cannot Be Removed by Surgery
|
Phase 1 | |
Completed |
NCT04535323 -
Platelet Rich Plasma for the Treatment of Genitourinary Syndrome of Menopause in Patients With Stage 0-III Breast Cancer
|
Phase 1 | |
Recruiting |
NCT05464810 -
Letrozole With and Without Simvastatin for the Treatment of Stage I-III Hormone Receptor Positive, HER2 Negative Breast Cancer
|
Early Phase 1 | |
Active, not recruiting |
NCT04249622 -
Rifaximin for the Treatment of Gastrointestinal Toxicities Related to Pertuzumab-Based Therapy in Patients With Stage I-III HER2 Positive Breast Cancer
|
Phase 2 | |
Withdrawn |
NCT03666819 -
Carbon Dioxide Fractional Laser in Treating Participants With Stage 0-III Hormone Receptor-Positive Breast Cancer With Vulvovaginal Atrophy
|
Phase 2 | |
Not yet recruiting |
NCT05930483 -
Remotely Delivered, Culturally Tailored Weight Loss Interventions Among Latina Breast Cancer Survivors
|
N/A | |
Recruiting |
NCT04862585 -
Safely Stopping Pre-medications in Patients With Breast Cancer Who Are Receiving Paclitaxel
|
Phase 2/Phase 3 | |
Withdrawn |
NCT05967286 -
Olaparib and Alpelisib for Treatment of Metastatic Breast Cancer, A ComboMATCH Treatment Trial
|
Phase 2 | |
Recruiting |
NCT04593277 -
Interactive Survivorship Program for the Improvement of Healthcare Resources in Adolescent and Young Adult Cancer Survivors, INSPIRE-AYA Study
|
N/A | |
Active, not recruiting |
NCT05086731 -
Mobile Health to Improve Oral Chemotherapy Adherence Among Women With Breast Cancer
|
N/A | |
Recruiting |
NCT05368428 -
Transcutaneous Electrical Nerve Stimulation in Chemotherapy Induced Peripheral Neuropathy in Patients With Stage I-III Early Stage Breast Cancer
|
N/A | |
Recruiting |
NCT04673448 -
Niraparib and TSR-042 for the Treatment of BRCA-Mutated Unresectable or Metastatic Breast, Pancreas, Ovary, Fallopian Tube, or Primary Peritoneal Cancer
|
Phase 1 | |
Not yet recruiting |
NCT05539365 -
Dendritic Cell-Based Treatment Plus Immunotherapy for the Treatment of Metastatic or Unresectable Triple Negative Breast Cancer
|
Phase 2 | |
Active, not recruiting |
NCT04086875 -
A Text-based Intervention in Improving Adherence to Hormone Therapy in Patients With Stage I-III Hormone Receptor Positive Breast Cancer
|
N/A | |
Completed |
NCT00507923 -
Tibetan Yoga in Improving Fatigue and Sleep in Participants With Stage I-III Breast Cancer
|
N/A | |
Recruiting |
NCT06058377 -
Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer
|
Phase 3 | |
Active, not recruiting |
NCT04514484 -
Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV
|
Phase 1 | |
Recruiting |
NCT05455658 -
STEMVAC in Patients With Early Stage Triple Negative Breast Cancer
|
Phase 2 | |
Recruiting |
NCT05674578 -
Health Coaching-Based Navigation at the Conclusion of Treatment for the Support of Black Breast Cancer Survivors
|
N/A |