Completed

CALORA Randomized Clinical Trial Of Adjuvant Chemotherapy For Radically Resected Loco-Regional Relapse Of Breast Cancer

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What is being tested

chemotherapy

+ radiation therapy

DrugRadiation
Who is being recruted

Breast Diseases+2

+ Breast Neoplasms

+ Neoplasms

From 18 to 120 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: July 2002
See protocol details

Summary

Principal SponsorETOP IBCSG Partners Foundation
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2002

Actual date on which the first participant was enrolled.

OBJECTIVES: Primary * Determine the efficacy of adjuvant chemotherapy, in terms of disease-free survival, in women with radically resected loco-regional relapsed breast cancer. Secondary * Determine the systemic disease-free and overall survival of patients treated with this regimen. * Determine the sites of recurrence, incidence of second (non-breast) malignancies, and causes of death without relapse of breast cancer in patients treated with this regimen. * Determine the quality of life of patients treated with this regimen (QOL portion closed 11/13/08). OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior chemotherapy (yes vs no), estrogen receptor (ER) positive and/or progesterone receptor (PR) positive (yes vs no), and location of recurrence (breast vs mastectomy scar/chest wall vs regional lymph nodes). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive radiotherapy\* within 6 months after surgery. * Arm II: Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients also receive radiotherapy\* within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy. NOTE: \*Patients with clear margins (R0) who received prior adjuvant radiotherapy are not required to receive further radiotherapy Patients with ER and/or PR positive tumors also receive standard hormonal therapy. Quality of life is assessed at baseline and at 9 and 12 months (QOL portion closed 11/13/08). Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 265 patients will be accrued for this study within 4 years.

Official TitleA Randomized Clinical Trial Of Adjuvant Chemotherapy For Radically Resected Loco-Regional Relapse Of Breast Cancer 
NCT00074152
Principal SponsorETOP IBCSG Partners Foundation
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

162 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 120 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesBreast NeoplasmsNeoplasmsNeoplasms by SiteSkin Diseases

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Group II

Active Comparator
Patients receive radiotherapy\* within 6 months after surgery.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 198 locations

Suspended

Kaiser Permanente - Deer Valley

Antioch, United StatesSee the location
Suspended

Kaiser Permanente - Fremont

Fremont, United States
Suspended

Kaiser Permanente Medical Center - Hayward

Hayward, United States
Suspended

Kaiser Permanente Medical Center - Oakland

Oakland, United States
Completed198 Study Centers