Intervention: miniICE
Trial phase: Phase 3
SMILES: COc1cc(C2c3cc4c(cc3C(OC3OC5COC(C)OC5C(O)C3O)C3COC(=O)C23)OCO4)cc(OC)c1O.O=C(O)C1(C(=O)O)CCC1.O=P1(NCCCl)OCCCN1CCCl.[CH3-].[CH3-].[Pt+2]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 85
Group description: Chemotherapy (+/- Radiation). Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients may receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy.

chemotherapy: Given within 10 weeks after surgery.
Eligibility criteria:
DISEASE CHARACTERISTICS:

Histologically confirmed invasive breast cancer

First local and/or regional (i.e., ipsilateral axillary or internal mammary lymph node region) recurrence after primary treatment with mastectomy or lumpectomy/quadrantectomy with clear surgical margins

Local failure is defined as a tumor recurrence in any soft tissue of the ipsilateral conserved breast or the chest wall, mastectomy scar, and/or skin
Regional failure is defined as a tumor recurrence in the ipsilateral axillary lymph nodes, extranodal soft tissue of the ipsilateral axilla, and/or ipsilateral internal mammary. Regional failure does not include supraclavicular lymph nodes or tumor in the opposite breast
No other prior recurrence in any site, including local

Surgical resection of the recurrence meeting 1 of the following criteria:

Uninvolved ("clear") margins and planned radiotherapy with at least 40 Gy for patients who had no prior adjuvant radiotherapy
Mastectomy of the recurrence with uninvolved ("clear") margins after lumpectomy/quadrantectomy alone for the primary
Adjuvant trastuzumab (Herceptin®) therapy or other HER-2 directed therapies are allowed for patients with HER-2 positive tumors and must be declared prior to randomization
No evidence of distant metastasis, including ipsilateral supraclavicular lymph nodes, by x-ray or CT scan of the chest, ultrasound or CT scan of the abdomen and pelvis, or bone scintigraphy only if alkaline phosphatase is > 2 times normal or if medically indicated (e.g., bone pain)
No macroscopically incomplete surgery
No bilateral malignancy except carcinoma in situ
No suspicious mass in the opposite breast unless that mass has been proven by biopsy to be benign

No skeletal pain of unknown cause

No hot spots on bone scan for which metastases cannot be ruled out by x-ray, MRI, and/or CT scan

Hormone receptor status:

Determined in the recurrent tumor by immunohistochemistry and/or ligand-binding assay
Estrogen receptor positive or negative
Progesterone receptor positive or negative

PATIENT CHARACTERISTICS:

Age

Minimum 18 years

Sex

Female

Menopausal status

Not specified

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

No elevated alkaline phosphatase

Renal

Not specified

Other

Fertile patients must use effective non-hormonal contraception
Medically suitable for chemotherapy of 3-6 months duration
No other primary malignant tumors except adequately treated carcinoma in situ of the cervix or nonmelanoma skin cancer
No non-malignant systemic disease that would preclude study treatment or prolong follow-up
No psychiatric or addictive disorder that would preclude giving informed consent
No history of noncompliance to medical regimens or potential for being unreliable

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

See Disease Characteristics

Endocrine therapy

Not specified

Radiotherapy

See Disease Characteristics

Surgery

See Disease Characteristics