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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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00074152
Acronym
CALOR
Enrollment
162
Registered
2003-12-11
Start date
2002-07-31
Completion date
2016-08-22
Last updated
2017-06-16

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

Conditions

Breast Cancer

Keywords

recurrent breast cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer

Brief summary

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.

Detailed description

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.

Interventions

DRUGchemotherapy

Given within 10 weeks after surgery.

RADIATIONradiation therapy

Given within 6 months after surgery

Sponsors

NSABP Foundation Inc
CollaboratorNETWORK
ETOP IBCSG Partners Foundation
Lead SponsorNETWORK

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 120 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
Disease-free Survival5 years after randomization

Secondary

MeasureTime frameDescription
Overall Survival5 years after randomization
Sites of First Failures5 years after randomizationTumor recurrence in the breast, lymph nodes or other areas of the body including bone, lung, liver, central nervous system, bone marrow

Countries

Australia, Belgium, Canada, Hungary, Netherlands, Peru, South Africa, Spain, Switzerland, United States

Participant flow

Participants by arm

ArmCount
Arm I
Observation (+/- Radiation). Patients receive radiotherapy\* within 6 months after surgery. radiation therapy: Given within 6 months after surgery
77
Arm II
Chemotherapy (+/- Radiation). 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. chemotherapy: Given within 10 weeks after surgery.
85
Total162

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath219
Overall StudyLack of Efficacy3424

Baseline characteristics

CharacteristicArm ITotalArm II
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
17 Participants31 Participants14 Participants
Age, Categorical
Between 18 and 65 years
60 Participants131 Participants71 Participants
Estrogen receptor (ER) status of primary tumor
negative
20 participants47 participants27 participants
Estrogen receptor (ER) status of primary tumor
positive
47 participants96 participants49 participants
Estrogen receptor (ER) status of primary tumor
unknown
10 participants19 participants9 participants
Estrogen receptor (ER) status of the isolated local or regional recurrence
Negative
29 participants58 participants29 participants
Estrogen receptor (ER) status of the isolated local or regional recurrence
Positive
48 participants104 participants56 participants
Location of isolated loco-regional recurrence (ILRR)
Breast
41 participants88 participants47 participants
Location of isolated loco-regional recurrence (ILRR)
Mx scar/chest wall
26 participants53 participants27 participants
Location of isolated loco-regional recurrence (ILRR)
Regional lymph nodes
10 participants21 participants11 participants
Menopausal Status at isolated loco-regional recurrence (ILRR)
post
63 participants128 participants65 participants
Menopausal Status at isolated loco-regional recurrence (ILRR)
pre
14 participants34 participants20 participants
Prior chemotherapy
No
25 participants61 participants36 participants
Prior chemotherapy
Yes
52 participants101 participants49 participants
Progesterone receptor (PgR) status of the isolated local or regional recurrence
negative
40 participants79 participants39 participants
Progesterone receptor (PgR) status of the isolated local or regional recurrence
not available
2 participants4 participants2 participants
Progesterone receptor (PgR) status of the isolated local or regional recurrence
positive
35 participants79 participants44 participants
Region of Enrollment
Australia
1 participants2 participants1 participants
Region of Enrollment
Canada
15 participants31 participants16 participants
Region of Enrollment
Hungary
17 participants33 participants16 participants
Region of Enrollment
Netherlands
6 participants12 participants6 participants
Region of Enrollment
Peru
1 participants1 participants0 participants
Region of Enrollment
South Africa
3 participants5 participants2 participants
Region of Enrollment
Spain
9 participants20 participants11 participants
Region of Enrollment
Switzerland
6 participants16 participants10 participants
Region of Enrollment
United States
19 participants42 participants23 participants
Sex: Female, Male
Female
77 Participants162 Participants85 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants
Surgery for primary tumor
Breast conserving
46 participants98 participants52 participants
Surgery for primary tumor
Mastectomy
31 participants64 participants33 participants
Time from primary surgery to isolated loco-regional recurrence (ILRR) surgery6.2 years5.5 years5.0 years

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 770 / 85
serious
Total, serious adverse events
0 / 7712 / 85

Outcome results

Primary

Disease-free Survival

Time frame: 5 years after randomization

ArmMeasureValue (NUMBER)
Arm IDisease-free Survival57 percentage of participants
Arm IIDisease-free Survival69 percentage of participants
Secondary

Overall Survival

Time frame: 5 years after randomization

ArmMeasureValue (NUMBER)
Arm IOverall Survival76 percentage of participants
Arm IIOverall Survival88 percentage of participants
Secondary

Sites of First Failures

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

Time frame: 5 years after randomization

ArmMeasureGroupValue (NUMBER)
Arm ISites of First FailuresSecon (non-breast) Malignancy0 participants
Arm ISites of First FailuresFailures34 participants
Arm ISites of First FailuresContralateral Breast1 participants
Arm ISites of First FailuresDistant22 participants
Arm ISites of First FailuresDeath without prior Cancer Event0 participants
Arm ISites of First FailuresSoft Tissue2 participants
Arm ISites of First FailuresLocal or Regional9 participants
Arm ISites of First FailuresBone5 participants
Arm ISites of First FailuresDeath, cause unknown2 participants
Arm ISites of First FailuresViscera15 participants
Arm ISites of First FailuresDeaths21 participants
Arm IISites of First FailuresViscera7 participants
Arm IISites of First FailuresDeaths9 participants
Arm IISites of First FailuresLocal or Regional6 participants
Arm IISites of First FailuresContralateral Breast1 participants
Arm IISites of First FailuresSecon (non-breast) Malignancy1 participants
Arm IISites of First FailuresDeath without prior Cancer Event1 participants
Arm IISites of First FailuresDeath, cause unknown0 participants
Arm IISites of First FailuresFailures24 participants
Arm IISites of First FailuresDistant15 participants
Arm IISites of First FailuresSoft Tissue0 participants
Arm IISites of First FailuresBone8 participants

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026