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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 (CALOR)

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ClinicalTrials.gov Identifier: NCT00074152
Recruitment Status : Completed
First Posted : December 11, 2003
Results First Posted : May 12, 2015
Last Update Posted : June 16, 2017
NSABP Foundation Inc
Information provided by (Responsible Party):
ETOP IBCSG Partners Foundation

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: chemotherapy Radiation: radiation therapy Phase 3

Detailed Description:



  • Determine the efficacy of adjuvant chemotherapy, in terms of disease-free survival, in women with radically resected loco-regional relapsed breast cancer.


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial Of Adjuvant Chemotherapy For Radically Resected Loco-Regional Relapse Of Breast Cancer
Study Start Date : July 2002
Actual Primary Completion Date : February 2014
Actual Study Completion Date : August 22, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Active Comparator: Arm I
Patients receive radiotherapy* within 6 months after surgery.
Radiation: radiation therapy
Given within 6 months after surgery

Experimental: Arm II
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.
Drug: chemotherapy
Given within 10 weeks after surgery.

Primary Outcome Measures :
  1. Disease-free Survival [ Time Frame: 5 years after randomization ]

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 5 years after randomization ]
  2. Sites of First Failures [ Time Frame: 5 years after randomization ]
    Tumor recurrence in the breast, lymph nodes or other areas of the body including bone, lung, liver, central nervous system, bone marrow

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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



  • Minimum 18 years


  • Female

Menopausal status

  • Not specified

Performance status

  • Not specified

Life expectancy

  • Not specified


  • Not specified


  • No elevated alkaline phosphatase


  • Not specified


  • 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


Biologic therapy

  • Not specified


  • See Disease Characteristics

Endocrine therapy

  • Not specified


  • See Disease Characteristics


  • See Disease Characteristics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00074152

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Sponsors and Collaborators
ETOP IBCSG Partners Foundation
NSABP Foundation Inc
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Study Chair: Stefan Aebi, MD Inselspital Bern, Switzerland
Study Chair: Irene L. Wapnir, MD Stanford Cancer Center, CA, USA
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: ETOP IBCSG Partners Foundation
ClinicalTrials.gov Identifier: NCT00074152    
Other Study ID Numbers: CDR0000343619
IBCSG-27-02 ( Other Identifier: IBCSG )
BIG-1-02 ( Other Identifier: Breast International Group )
2005-001484-64 ( EudraCT Number )
First Posted: December 11, 2003    Key Record Dates
Results First Posted: May 12, 2015
Last Update Posted: June 16, 2017
Last Verified: May 2017
Keywords provided by ETOP IBCSG Partners Foundation:
recurrent breast cancer
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases