Clinical trial · Interventional
Adjuvant Chemotherapy in Treating Women Who Have Undergone Resection for Relapsed Breast Cancer; Chemotherapy as Adjuvant for LOcally Recurrent Breast Cancer
A Randomized Clinical Trial Of Adjuvant Chemotherapy For Radically Resected Loco-Regional Relapse Of Breast Cancer
- 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. It is not yet known whether chemotherapy is effective in treating women who have undergone surgery and radiation therapy for relapsed breast cancer. PURPOSE: Randomized phase III trial to determine the effectiveness of adjuvant chemotherapy in treating women who have undergone resection for local and/or regional relapsed 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chemotherapy | Drug | Chemotherapy | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm I
- description
- Patients receive radiotherapy\* within 6 months after surgery.
- interventionNames
- Radiation: radiation therapy
- type
- EXPERIMENTAL
- label
- Arm II
- description
- 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.
- interventionNames
- Drug: chemotherapy
Primary outcomes (1)
- measure
- Disease-free Survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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 CharacteristicsReferences
Publications (4)
- RESULTWapnir IL, Aebi S, Gelber S, Anderson SJ, Lang I, Robidoux A, Mamounas EP, Wolmark N. Progress on BIG 1-02/IBCSG 27-02/NSABP B-37, a prospective randomized trial evaluating chemotherapy after local therapy for isolated locoregional recurrences of breast cancer. Ann Surg Oncol. 2008 Nov;15(11):3227-31. doi: 10.1245/s10434-008-0129-2. Epub 2008 Sep 11. PMID 18784962
- RESULTWapnir IL, Aebi S, Geyer CE, Zahrieh D, Gelber RD, Anderson SJ, Robidoux A, Bernhard J, Maibach R, Castiglione-Gertsch M, Coates AS, Piccart MJ, Clemons MJ, Costantino JP, Wolmark N; IBCSG; BIG; NSABP. A randomized clinical trial of adjuvant chemotherapy for radically resected locoregional relapse of breast cancer: IBCSG 27-02, BIG 1-02, and NSABP B-37. Clin Breast Cancer. 2008 Jun;8(3):287-92. doi: 10.3816/CBC.2008.n.035. PMID 18650162
- RESULTAebi S, Gelber S, Anderson SJ, Lang I, Robidoux A, Martin M, Nortier JW, Paterson AH, Rimawi MF, Canada JM, Thurlimann B, Murray E, Mamounas EP, Geyer CE Jr, Price KN, Coates AS, Gelber RD, Rastogi P, Wolmark N, Wapnir IL; CALOR investigators. Chemotherapy for isolated locoregional recurrence of breast cancer (CALOR): a randomised trial. Lancet Oncol. 2014 Feb;15(2):156-63. doi: 10.1016/S1470-2045(13)70589-8. Epub 2014 Jan 16. PMID 24439313
- DERIVEDWapnir IL, Price KN, Anderson SJ, Robidoux A, Martin M, Nortier JWR, Paterson AHG, Rimawi MF, Lang I, Baena-Canada JM, Thurlimann B, Mamounas EP, Geyer CE Jr, Gelber S, Coates AS, Gelber RD, Rastogi P, Regan MM, Wolmark N, Aebi S; International Breast Cancer Study Group; NRG Oncology, GEICAM Spanish Breast Cancer Group, BOOG Dutch Breast Cancer Trialists' Group; Breast International Group. Efficacy of Chemotherapy for ER-Negative and ER-Positive Isolated Locoregional Recurrence of Breast Cancer: Final Analysis of the CALOR Trial. J Clin Oncol. 2018 Apr 10;36(11):1073-1079. doi: 10.1200/JCO.2017.76.5719. Epub 2018 Feb 14. PMID 29443653