German Preoperative Adriamycin Docetaxel Study

October 16, 2007 updated by: German Breast Group

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Unilateral primary carcinoma of the breast, confirmed histologically by core-cut needle or incisional biopsy. Fine needle aspiration is not sufficient.
  • Bidimensionally measurable tumour, either by mammography or breast ultrasound or breast MRI
  • Primary tumour >= 3 cm in largest diameter. In patients with multifocal or multicentric breast cancer the largest lesion should be measured.
  • No evidence of distant metastases (as confirmed by chest x-ray, liver ultrasound and bone scintigraphy)
  • Age >= 18 years and <= 70 years.
  • Life expectancy at least 10 years, ignoring the diagnosis of cancer.
  • Karnofsky index >=70%.
  • Adequate haematologic, renal and hepatic function (WBC >4000, platelets >100000, bilirubin, serum creatinine and transaminases within the normal range).
  • Anamnestic and electrocardiographic evidence of normal cardiac function, without or with medication. Normal cardiac function measured by echocardiography or MUGA-scan.
  • Negative pregnancy test and appropriate non-hormonal contraception in fertile women.
  • Written informed consent and presumed compliance of the patients.

Exclusion Criteria:

  • Locally advanced (stage T4), bilateral, metastatic, or inflammatory breast cancer (tethering or dimpling of the skin as well as nipple inversion may not easily be interpreted as skin infiltration). If one of these conditions is suspected it has to be excluded before enrollment onto study.
  • Previous treatment for breast cancer, including surgery, radiation, cytotoxic or endocrine treatments. Surgical diagnostic procedures are allowed.
  • Previous malignancy other than breast cancer or non-invasive breast lesions if the disease-free interval is less than 10 years.
  • Previous cytotoxic treatment for any condition.
  • Preexisting neurotoxicity greater than grade II (WHO).
  • Active infection or other significant illness that could influence tolerability of treatment.
  • Current treatment with sex hormones (treatment has to be discontinued before the start of systemic therapy).
  • Psychiatric illness or drug addiction that would preclude obtaining informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary endpoint is defined as no microscopic evidence of viable tumour in the resected breast specimen
Time Frame: Post surgery
Post surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Endpoints are (1) clinical partial or complete response and (2) clinical complete response
Time Frame: Post surgery
Post surgery
Endpoint is breast conservation without the need for autologous or heterologous reconstruction
Time Frame: Post surgery
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
2 years post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

German Breast Group

Investigators

  • Principal Investigator: Manfred Kaufmann, MD, J. W. Goethe University, School of Medicine, Dep. of Gynecology and Obstetrics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 1998

Study Completion (Actual)

June 1, 1999

Study Registration Dates

First Submitted

October 12, 2007

First Submitted That Met QC Criteria

October 12, 2007

First Posted (Estimate)

October 15, 2007

Study Record Updates

Last Update Posted (Estimate)

October 17, 2007

Last Update Submitted That Met QC Criteria

October 16, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gepardo

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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