Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
GBG Forschungs GmbH
With
German Adjuvant Breast Cancer Group
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
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