Clinical trial · Interventional
Combination Chemotherapy Compared With Observation After Surgery in Treating Women With Relapsed Nonmetastatic Breast Cancer
Randomized And Multicentric Phase III Study Evaluating The Benefit By Using A Chemotherapy With FEC 100 And Docetaxel In Non Metastatic Breast Cancer Which Has Relapsed After A Conservative Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug, and giving them after surgery, may kill any remaining tumor cells following surgery. It is not yet known whether combination chemotherapy is more effective than observation in treating relapsed nonmetastatic breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with that of observation in treating women who have undergone surgery for relapsed nonmetastatic breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| anastrozole | Drug | Anastrozole | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| docetaxel | Drug | Docetaxel | ALIAS |
| epirubicin hydrochloride | Drug | Epirubicin | ALIAS |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| goserelin acetate | Drug | Goserelin | ALIAS |
| tamoxifen citrate | Drug | Tamoxifen | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Evaluation of the disease free survival
- timeFrame
- 5 years
Secondary outcomes (1)
- measure
- Evaluation of the overall survival
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the breast * No contralateral breast cancer * Local tumor recurrence more than 6 months after conservative surgery * Complete or conservative resection of the recurrent tumor NOTE: Initial complete surgical resection not allowed * No local inflammatory disease or disease that is not amenable to complete surgical resection * No positive axillary lymph nodes * No distant metastases, including subclavicular lymph nodes * Hormone receptor status: * Hormone receptor status known PATIENT CHARACTERISTICS: Age * 18 to 65 Sex * Female Menopausal status * Menopausal status known Performance status * ECOG 0-1 Life expectancy * Not specified Hematopoietic * Neutrophil count at least 2,000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin no greater than upper limit of normal (ULN) * Transaminases no greater than 1.5 times ULN * Alkaline phosphatase no greater than 2.5 times ULN * No chronic hepatitis B * No active hepatitis C Renal * Not specified Cardiovascular * Cardiac function normal by echocardiogram or isotopes Other * No contraindications to anthracyclines such as any of the following: * Prior doxorubicin over 300 mg/m\^2 * Prior epirubicin over 600 mg/m\^2 * Prior mitoxantrone over 90 mg/m\^2 * No other invasive malignancy * No chronic somatic or psychiatric condition that would preclude study participation * No familial, social, geographic, or psychological reason that would preclude study participation * Not pregnant * Fertile patients must use effective contraception * HIV negative * CA 153 no greater than 2 times ULN PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Patient Characteristics-Other * No prior neoadjuvant chemotherapy Endocrine therapy * No prior neoadjuvant hormonal therapy Radiotherapy * No prior neoadjuvant radiotherapy Surgery * See Disease Characteristics * At least 41 days since prior surgery
References
Publications (0)
Data not yet available