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A Randomized, Multicenter, Open Phase III Study Comparing a Dose-Intensified 8 Week Schedule of Adriamycin and Docetaxel (ADOC) With a Sequential 24 Week Schedule of Adriamycin/Cyclophosphamide Followed by Docetaxel (AC-DOC) Regimen as Preoperative Therapy in Patients With Operable Carcinoma of the Breast (T2-3 N0-2 M0)


Phase 3
18 Years
N/A
Not Enrolling
Female
Primary Breast Cancer

Thank you

Trial Information

A Randomized, Multicenter, Open Phase III Study Comparing a Dose-Intensified 8 Week Schedule of Adriamycin and Docetaxel (ADOC) With a Sequential 24 Week Schedule of Adriamycin/Cyclophosphamide Followed by Docetaxel (AC-DOC) Regimen as Preoperative Therapy in Patients With Operable Carcinoma of the Breast (T2-3 N0-2 M0)


Inclusion Criteria:



- Pre-study screening performed according to section 7.1

- Unilateral primary carcinoma of the breast, confirmed histologically by core or
tru-cut biopsy. Fine-needle aspiration is not sufficient. Incisional biopsy is only
allowed if less than 20% of the tumor is excised.

- Two-dimensionally measurable (mammography, ultrasound, or MRI) breast tumor

- Primary tumor >= 2 cm in largest diameter by either palpation, sonography or
mammography, or breast MRI. In patients with multifocal or multicentric breast
cancer, the largest lesion should be measured.

- No evidence of distant metastases

- Life expectancy of at least 10 years, disregarding the diagnosis of cancer.

- Karnofsky index >= 70%.

- Age 18 years or older.

- Adequate hematological, renal, and hepatic function (WBC > 4000, platelets > 100 000,
bilirubin, serum creatinine and transaminases within 1.5 × upper normal range).

- Evidence of normal cardiac function (with or without medication) from the patient
history and from electrocardiography. Normal function is confirmed by
echocardiography or multiple gated acquisition (MUGA) scan.

- Negative pregnancy test and appropriate nonhormonal contraception in fertile women.
Intrauterine pessaries with progestogens are allowed.

- Written informed consent and assumed compliance for therapy and follow up of the
patients.

- Consent of patient, pathologist and investigator to supply tumor material of biopsy
and surgery for central pathologic evaluation and examination of predictive factors.

Exclusion Criteria:

- Locally advanced (stage T4), bilateral, metastatic, or inflammatory breast cancer. If
one of these conditions is suspected, it has to be excluded before enrollment into
study.

- Previous treatment for breast cancer, including surgery, radiation, cytotoxic, or
endocrine treatments.

- Previous malignancy other than breast cancer or noninvasive breast cancer if the
disease-free interval is less than 10 years.

- Previous cytotoxic treatment for any condition.

- Preexisting neurotoxicity greater than grade II.

- Active infection or other significant illness that could influence the 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome Measure:

Pathological locoregional complete tumor response (pCR) between both arms

Outcome Time Frame:

3 years

Safety Issue:

Yes

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

Gepar-Duo

NCT ID:

NCT00793377

Start Date:

Completion Date:

September 2001

Related Keywords:

  • Primary Breast Cancer
  • Breast Neoplasms

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