ow-dose Cytotoxics as Anti-angiogenesis Treatment” following AdjuvantInduction Chemotherapy for Patients with ER-negative and PgR-negativeBreast CancerMaintenance Chemotherapy in Hormone Non- Responsive Breast Cancer - Maintenance Chemotherapy in Hormone Non-Responsive Breast Cancer
- Conditions
- Histologically proven ER-negative and PgRnegative breast cancer with either a total mastectomy with axillary clearance or a lesser procedure with axillary lymph node dissection or sentinel node procedure, and classified as T1a,b,c, T2, T3, or pT4 with minimal dermal invasion, Nx, pN0, pSentN0, pN1, or pN2, and M0. Patients with disease defined as SNB positive are eligible only if they have undergone an axillary dissection, OR are SNB micrometastatic and are randomized to IBCSG Trial 23-01.MedDRA version: 9.1Level: LLTClassification code 10006190Term: Breast cancer invasive NOS
- Registration Number
- EUCTR2005-005666-36-SE
- Lead Sponsor
- International Breast Cancer Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 1080
Premenopausal or postmenopausal patients with histologically proven primary breast cancer.
The primary tumor must be classified as T1a,b,c, T2, T3, or pT4 with minimal dermal invasion, Nx, pN0, pSentN0, pN1, or pN2, and M0. Patients with disease defined as SNB positive are eligible only if they have undergone an axillary dissection, OR are SNB micrometastatic and are randomized to IBCSG Trial 23-01. The tumor must be confined to the breast, without detected metastases elsewhere.
Estrogen and progesterone receptor status must be known by immunohistochemistry, before randomization, and both must be negative, which is defined as < 10% of the tumor cells positive by immunohistochemical evaluation.
HER2 status must be known and determined by either immunohistochemistry or FISH before randomization.
The induction chemotherapy must be approved by the IBCSG Scientific Committee and must begin (or have begun) within 8 weeks of definitive surgery.
Patients must have had either:
• a total mastectomy. Radiotherapy is optional after mastectomy. OR
• a breast-conserving procedure (lumpectomy, quadrantectomy or partial mastectomy with negative margins) with radiotherapy planned. Radiation therapy to the conserved breast is required.
Patient must have had pathological axillary staging performed on a specimen from axillary clearance or sentinel node biopsy. In order to be classified as pN0, patients who receive axillary clearance must have a minimum of 6 lymph nodes available for pathological examination.
Patients must have completed pre-randomization Quality of Life (QL) Forms. The only
exceptions are cognitive or physical impairment that interferes with QL assessment or inability to read any of the languages available on IBCSG QL forms.
The patient must be in adequate health to begin or continue with induction chemotherapy or start maintenance chemotherapy:
• WBC greater than 3.0x109/l
• Platelets greater than 100x109/l
• Serum creatinine below 120 µmol/l, adequate liver values
• Serum bilirubin below 20 µmol/l
• No cystitis
• No evidence of any toxicity grade 2 or worse (CTC), in particular: nausea, vomiting,
diarrhea, mucositis (stomatitis or any other mucousal inflammation), or epigastric pain.
Written informed consent dated and signed by both patient and investigator.
Must be geographically accessible for follow-up.
Patients must be informed of, and agree to, data and material transfer and handling, in accordance with national data protection guidelines and Swiss data protection law (as IBCSG is a foundation under Swiss law).
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Patients with T4 carcinoma with ulceration of skin, infiltration of skin (except pathologically minimal dermal involvement), peau d'orange or inflammatory breast cancer, or with distant metastases. Any suspicious manifestation requires appropriate investigation to exclude metastasis.
Patients with bilateral malignancies (except in situ carcinoma), or with a suspicious mass in the opposite breast, unless that mass has been proven by biopsy to be benign.
Patients, who, before start of induction chemotherapy, had a skeletal pain of unknown cause, elevated alkaline phosphatase, or a bone scan showing hot spots for which metastases cannot be ruled out by X-ray, MRI and/or CT.
Patients in whom the margins of the resected specimen (whether mastectomy or local excision) contained invasive tumor. Patients who have local excision with a positive margin may become eligible if within 8 weeks from first surgery they undergo adequate resection or mastectomy with clear margins.
Patients with previous or concomitant malignancy EXCEPT adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix, or contra- or ipsilateral in situ breast carcinoma.
Patients who have received prior therapy for breast cancer other than primary irradiation, approved induction regimen, or trastuzumab. Prior endocrine therapy for breast cancer or prevention is not permitted.
Patients with non-malignant systemic diseases that would prevent them from undergoing any of the treatment options, or would prevent prolonged follow-up.
Patients with psychiatric or addictive disorders that would prevent them from giving informed consent to therapy and randomization.
Patients who either have been pregnant or who have lactated within 6 months of diagnosis.
Patients with a history of noncompliance to medical regimens and patients who are considered potentially unreliable.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method