Chemotherapy for Radically Resected Loco-regional Relapse A randomized clinical trial of adjuvant chemotherapy for radically resected loco-regional relapse of breast cancer Chemotherapy vs. Observation - Chemotherapy for Radically Resected Loco-regional Relapse

• Register: EUCTR
• Last refreshed on: 7 October 2014
• Main ID: EUCTR2005-001484-64-BE
• Date of registration: 23/03/2006
• Prospective Registration: Yes
• Primary sponsor: International Breast Cancer Study Group (IBCSG)
• Public title: Chemotherapy for Radically Resected Loco-regional Relapse A randomized clinical trial of adjuvant chemotherapy for radically resected loco-regional relapse of breast cancer Chemotherapy vs. Observation - Chemotherapy for Radically Resected Loco-regional Relapse
• Scientific title: Chemotherapy for Radically Resected Loco-regional Relapse A randomized clinical trial of adjuvant chemotherapy for radically resected loco-regional relapse of breast cancer Chemotherapy vs. Observation - Chemotherapy for Radically Resected Loco-regional Relapse
• Date of first enrolment: 06/04/2006
• Target sample size: 265
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-001484-64
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: No adjuvant chemotherapy (observation)

Countries of recruitment

Belgium

Key inclusion & exclusion criteria

Inclusion criteria:
Histologically verified first local and/or regional (ipsilateral axillary or internal mammary lymph node) recurrence of invasive breast cancer following primary treatment with mastectomy or lumpectomy/quadrantectomy with clear surgical margins. Regional lymph node staging and radiation therapy at primary treatment are not eligibility criteria.
Local failure is defined as tumor recurrence in any soft tissue of the ipslateral 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 mammography. Regional failure does not include supraclavicular lymph nodes or tumor in the opposite breast.

Surgical resection of the recurrence with uninvolved (“clear”) margins (R0). Planned radiotherapy with =40 Gy for patients who had no adjuvant radiation treatment OR
Mastectomy of the recurrence with uninvolved ('clear') margins (R0) after lumpectomy/quadrantectomy alone for the primary. Radiotherapy is recommended but NOT mandatory OR
Surgical resection with microscopically involved margins (R1): Patients are eligible only if radiation treatment with =40 Gy is planned. The radiation therapy must at least involve the positive resection margin and a safety margin. Localized fields with techniques using an adequate radiation dose ( such as electron beam therapy or brachytherapy) are permitted.

No evidence of distant metastasis on standard staging examinations (x-ray or CT scan of the chest, ultrasound or CT scan of the abdomen and pelvis, bone scintigraphy) only if alkaline phosphatase is > 2x normal or if medically indicated (e.g. bone pain).

Measurement of hormone receptors in the recurrent tumor by the locally preferred method (immunohistochemistry and/or ligand binding assay). Each institution should use its own standard for defining endocrine-responsive disease (ER+ and/or PgR+). These standards should be defined prospectively.

Medically suitable for chemotherapy of 3 to 6 months duration.

Written informed consent.

Patients must be informed of, and agree to, data and material transfer and handling, in accordance with national data protection guidelines.

Patients must be geographically accessible for follow-up.
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) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Patients with macroscopically incomplete surgery.

Patients with microscopically involved margins of resection and impossibility (because of prior radiotherapy) to apply =40 Gy of local radiation therapy.

Patients with bilateral malignancy (except in situ carcinoma), or with a suspicious mass in the opposite breast, unless that mass has been proven by biopsy to be benign.

Evidence of distant metastasis (including ipsilateral supraclavicular lymph nodes).

Patients who have had a prior recurrence in any site, including local (except the first loco-regional recurrence described under inclusion criteria).

Patients, who, before randomization, have 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 with other primary malignant tumors except adequately treated carcinoma in situ of the uterine cervix and non-melanoma skin cancer.

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 randomization and therapy.

Patients with a history of noncompliance to medical regimens and patients who are considered potentially unreliable.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

Patients with radically treated isolated local and/or regional recurrence of invasive breast cancer after mastectomy or breast-conserving surgery.
MedDRA version: 8.1 Level: LLT Classification code 10006190 Term: Breast cancer invasive NOS

Intervention(s)

Pharmaceutical Form:

Primary Outcome(s)

Secondary Objective: Treatment comparisons will also be based upon the following additional endpoints:
• Sites of first recurrence after randomization to this trial
• Incidence of second (non-breast) malignancies
• Causes of deaths without relapse of breast cancer

Main Objective: To evaluate the efficacy of adjuvant chemotherapy after radical local treatment of a first loco-regional recurrence of breast cancer.
Treatment comparisons will be based upon the following endpoints:
• Disease-free survival (primary end point)
• Overall survival, systemic relapse and systemic disease-free survival

Primary end point(s): First confirmation of recurrence (local, regional or distant), second primary (including non-breast) tumor, and/or death.

Disease-free survival (DFS) is defined as the time from randomization to local, regional or distant recurrence (including recurrence restricted to the breast after breast conserving treatment), appearance of a second primary tumor, beginning of a new cancer-specific therapy, or death from any cause, whichever occurs first. An in situ recurrence either in the ipsilateral or in the contralateral breast is not considered a recurrence.

Secondary ID(s)

IBCSG 27-02/BIG 1-02/GEICAM 2002/04