Completed
CALOR

Adjuvant Chemotherapy in Treating Women Who Have Undergone Resection for Relapsed Breast Cancer; Chemotherapy as Adjuvant for LOcally Recurrent Breast Cancer

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What is being tested

chemotherapy

+ radiation therapy
Drug
Radiation
Who is being recruted

Breast Cancer

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: June 16, 2017
Sourced from a government-validated database.Claim as a partner
Study start date: July 1, 2002Actual date on which the first participant was enrolled.

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. 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 
Principal SponsorETOP IBCSG Partners Foundation
Last updated: June 16, 2017
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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
FemaleBiological sex of participants that are eligible to enroll.
From 18 to 120 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Breast Cancer
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
Active Comparator
Patients receive radiotherapy\* within 6 months after surgery.
Group II
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.
Study Objectives
Primary Objectives

Secondary Objectives

Tumor recurrence in the breast, lymph nodes or other areas of the body including bone, lung, liver, central nervous system, bone marrow

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 199 locations
Suspended
Kaiser Permanente - Deer ValleyAntioch, United StatesSee the location
Suspended
Kaiser Permanente - FremontFremont, United States
Suspended
Kaiser Permanente Medical Center - HaywardHayward, United States
Suspended
Kaiser Permanente Medical Center - OaklandOakland, United States
Completed199 Study Centers