German Preoperative Adriamycin Docetaxel Study
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|ClinicalTrials.gov Identifier: NCT00543829|
Recruitment Status : Completed
First Posted : October 15, 2007
Last Update Posted : October 17, 2007
The primary objective of this trial is to determine the rate of pathologically complete remissions following a preoperative dose-intensified therapy with doxorubicin and docetaxel with or without tamoxifen in patients with operable carcinoma of the breast. Secondary aims are to assess the rate of clinical complete and partial responses, of breast-conserving operations, and the toxicity of chemotherapy with and without tamoxifen.
Women meeting the following criteria will be eligible for the study: operable breast cancer (T³3cm N0-2 M0), histologically confirmed diagnosis by core-cut needle or incisional biopsy, and measurable disease by mammography or sonography or breast MRI (best appropriate method has to chosen by investigator). After the patients have given written informed consent, they will be randomised to the study treatments. All patients are scheduled to receive 4 cycles of combination chemotherapy consisting of doxorubicin 50 mg/m² (15-min i.v. infusion) and docetaxel 75 mg/m² (1-h i.v. infusion). The patients allocated to group I additionally receive oral doses of tamoxifen 30 mg once daily, starting on the first day of chemotherapy, while chemotherapy alone is administered to patients of group II. Cycles should be repeated every 14 days, followed by surgery 8 weeks after initiation of the trial. Surgery consists of removal of the remaining tumour (breastconserving resection or mastectomy) and axillary dissection. Patients with no response or even progression of the primary tumour can be treated to the discretion of the investigator but should be followed up according to protocol. If a partial or complete tumour response has been achieved, radiotherapy is given to the remaining breast in patients undergoing breast conserving therapy, and tamoxifen treatment is continued for a further 5 years.
Response will be assessed between the 4th cycle and surgery, using the best appropriate method. Clinical evaluation should be performed after each cycle. It is planned to recruite 200 patients during a period of 1 year.
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasms||Drug: doxorubicin, docetaxel, tamoxifen Drug: doxorubicin, docetaxel||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomised, Controlled, Open Phase II b Study Comparing a Combination of Dose-Intensified Doxorubicin and Docetaxel With or Without Tamoxifen as Preoperative Therapy in Patients With Operable Carcinoma of the Breast (T>=3cm N0-2 M0)|
|Study Start Date :||April 1998|
|Actual Study Completion Date :||June 1999|
4 cycles of doxorubicin and docetaxel with tamoxifen
Drug: doxorubicin, docetaxel, tamoxifen
Every 14 days to a total of 4 cycles of doxorubicin (50 mg/m², 15 minutes i.v. infusion) and docetaxel (75 mg/m², 1 hour i.v. infusion) with tamoxifen (30 mg tablet p.o. for 5 years post surgery)
Active Comparator: 2
4 cycles of doxorubicin and docetaxel without tamoxifen
Drug: doxorubicin, docetaxel
Every 14 days to a total of 4 cycles of doxorubicin (50 mg/m², 15 minutes i.v. infusion) and docetaxel (75 mg/m², 1 hour i.v. infusion)
- The primary endpoint is defined as no microscopic evidence of viable tumour in the resected breast specimen [ Time Frame: Post surgery ]
- Endpoints are (1) clinical partial or complete response and (2) clinical complete response [ Time Frame: Post surgery ]
- Endpoint is breast conservation without the need for autologous or heterologous reconstruction [ Time Frame: Post surgery ]
- Endpoints are the frequency of grade III and IV haematological and non-haematological toxicities during chemotherapy and delayed cardiotoxicity [ Time Frame: 2 years post surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00543829
|Principal Investigator:||Manfred Kaufmann, MD||J. W. Goethe University, School of Medicine, Dep. of Gynecology and Obstetrics|