eo-Adjuvant Trial Add-O

Conditions: Patients with histological tumor residuals after preoperative anthracycline and taxane containing chemotherapy for primary breast cancer
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2004-002355-14-AT

Lead Sponsor: GBG Forschungsgesellschaft mbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 654

Inclusion Criteria

- Written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures;
- Complete baseline documentation sent to GBG;
- Prior preoperative chemotherapy for at least 4 cycles, of which at least two must contain a taxane and an anthracycline given within a clinical trial approved by the protocol board;
- Completely resected unilateral or bilateral primary carcinoma of the breast with histologically detectable tumor residuals (ypT1-4) and or histologically confirmed involvement of axillary nodes (ypN1-3). Complete axillary clearance is mandatory, sentinel node biopsy alone is not allowed in node positive cases;
- A maximum interval from date of axillary surgery to entering this trial of 3 years;
- Age 18 years or older;
- Karnofsky index >= 70%;
- Life expectancy of at least 10 years, disregarding the diagnosis of cancer;
- No clinical evidence of local recurrence or distant metastases. Complete staging work-up within 3 months prior to registration. All patients must have (bilateral) mammography or breast MRI, breast ultrasound, chest X-ray, ultrasound or CT scan of the liver, and bone scan (within 8 months). In case of a positive bone scan, bone X-ray is mandatory. Other tests may be performed as clinically indicated;
- Adequate renal and hepatic function (serum creatinine, bilirubin, and transaminases within 1.5 × upper normal range);
- Tissue block centrally available for further biological tests;
- Patients must be available and compliant for treatment and follow-up. Patients registered on this trial must be treated and followed up at the participating center.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 654
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 654

Exclusion Criteria

- Known hypersensitivity reaction to the investigational compound;
- Prior postoperative chemotherapy;
- Prior treatment with bisphosphonates since breast cancer surgery;
- Pregnant or lactating patients. Patients of childbearing potential must have a negative pregnancy test (urine or serum) within 14 days prior to registration and must implement adequate non-hormonal contraceptive measures during study treatment;
- History of diseases with influence on bone metabolism, such as Paget’s disease of bone and primary hyperparathyroidism or osteoporosis requiring treatment at the time of study entry or considered likely to become necessary within the six months
- Other serious illness or medical condition that may interfere with the understanding and giving of informed consent and the conduct of the study
- Prior or concomitant secondary malignancy (except non-melanomatous skin cancer or carcinoma in situ of the uterine cervix)
- Concurrent treatment with other experimental drugs or any other anti-cancer therapy;
- Serum creatinine >= 3 mg/dl (265 micromol/L)
- Corrected (adjusted for serum albumin) serum calcium concentration < 8.0 mg/dl (2.00 mmol/L) or >= 12.0 mg/dl (3.00 mmol/L)
- Concurrent treatment with sex hormones. Prior treatment must be stopped before study entry;
- Male patients.