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Randomized clinical trial of adjuvant chemotherapy for cancer breast with recurrence Loco regional Recessed Radically chemo therapy vs. observation

Randomized clinical trial of adjuvant chemotherapy for cancer breast with recurrence Loco regional Recessed Radically chemo therapy vs. observation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-079-03
Enrollment
Unknown
Registered
2004-01-22
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Radical local treatment (+ hormonal treatment if appropriate) + 3-6 months of Chemotherapy. Group name:Hormone treatment Type of group
Radical locat treatment (+ hormonal treatment if appropriate)

Sponsors

INTERNATIONAL BREAST CANCER STUDY GROUP - IBCSG,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: not contemplated

Exclusion criteria

Exclusion criteria: not contemplated

Design outcomes

Primary

MeasureTime frame
Outcome name:First confirmation of recurrence (local, regional or distant), second primary (including non-breast) tumor, and / or death. Disease-free survival (DFS) is defmed 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 siiu recurrence either in the ipsilateral or in the contralateral breast is not considered a recurrence (but must be reported on the Follow-up Form). Measure:To evaluate the efficacy of adyunvant chemotherapy after radical resection of the first loco regional recurrence of breast cancer. Timepoints:6 weeks ; Outcome name:Overall survival (OS) is defmed as the time from randomization to death from any cause. Systemic relapse is defmed as any recurrent or metastatic disease in sites other than the local mastectomy scar / chest wall / skin, the ipsilateral breast in case of breast conservation, or the ipsilateral axilla and intemal mammary lymph nodes. Measure:Compare the two arms of treatment: survival free of systemic disease and quality of life. Timepoints:6 weeks

Countries

Peru, United States

Outcome results

None listed

Source: REPEC (via WHO ICTRP)