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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00074152




Registration number
NCT00074152
Ethics application status
Date submitted
10/12/2003
Date registered
11/12/2003
Date last updated
16/06/2017

Titles & IDs
Public title
Adjuvant Chemotherapy in Treating Women Who Have Undergone Resection for Relapsed Breast Cancer; Chemotherapy as Adjuvant for LOcally Recurrent Breast Cancer
Scientific title
A Randomized Clinical Trial Of Adjuvant Chemotherapy For Radically Resected Loco-Regional Relapse Of Breast Cancer
Secondary ID [1] 0 0
IBCSG-27-02
Secondary ID [2] 0 0
CDR0000343619
Universal Trial Number (UTN)
Trial acronym
CALOR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - chemotherapy
Treatment: Other - radiation therapy

Active comparator: Arm I - Patients receive radiotherapy\* 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.


Treatment: Drugs: chemotherapy
Given within 10 weeks after surgery.

Treatment: Other: radiation therapy
Given within 6 months after surgery
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disease-free Survival
Timepoint [1] 0 0
5 years after randomization
Secondary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
5 years after randomization
Secondary outcome [2] 0 0
Sites of First Failures
Timepoint [2] 0 0
5 years after randomization

Eligibility
Key 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
Minimum age
18 Years
Maximum age
120 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/08/2016
Sample size
Target
Accrual to date
Final
162
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Mater Hospital - North Sydney - North Sydney
Recruitment hospital [2] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [3] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [4] 0 0
Peter MacCallum Cancer Centre - East Melbourne
Recruitment hospital [5] 0 0
Maroondah Hospital - East Ringwood
Recruitment postcode(s) [1] 0 0
2060 - North Sydney
Recruitment postcode(s) [2] 0 0
5042 - Bedford Park
Recruitment postcode(s) [3] 0 0
3128 - Box Hill
Recruitment postcode(s) [4] 0 0
3002 - East Melbourne
Recruitment postcode(s) [5] 0 0
3135 - East Ringwood
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Delaware
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Iowa
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United States of America
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Kansas
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United States of America
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Kentucky
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United States of America
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Massachusetts
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United States of America
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Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Montana
Country [15] 0 0
United States of America
State/province [15] 0 0
Nebraska
Country [16] 0 0
United States of America
State/province [16] 0 0
Nevada
Country [17] 0 0
United States of America
State/province [17] 0 0
New Jersey
Country [18] 0 0
United States of America
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New York
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United States of America
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North Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Ohio
Country [21] 0 0
United States of America
State/province [21] 0 0
Oregon
Country [22] 0 0
United States of America
State/province [22] 0 0
Pennsylvania
Country [23] 0 0
United States of America
State/province [23] 0 0
South Carolina
Country [24] 0 0
United States of America
State/province [24] 0 0
Tennessee
Country [25] 0 0
United States of America
State/province [25] 0 0
Texas
Country [26] 0 0
United States of America
State/province [26] 0 0
Virginia
Country [27] 0 0
United States of America
State/province [27] 0 0
West Virginia
Country [28] 0 0
United States of America
State/province [28] 0 0
Wisconsin
Country [29] 0 0
United States of America
State/province [29] 0 0
Wyoming
Country [30] 0 0
Belgium
State/province [30] 0 0
Brussels
Country [31] 0 0
Canada
State/province [31] 0 0
Alberta
Country [32] 0 0
Canada
State/province [32] 0 0
Ontario
Country [33] 0 0
Canada
State/province [33] 0 0
Quebec
Country [34] 0 0
Hungary
State/province [34] 0 0
Budapest
Country [35] 0 0
Netherlands
State/province [35] 0 0
Arnhem
Country [36] 0 0
Netherlands
State/province [36] 0 0
Leiden
Country [37] 0 0
Netherlands
State/province [37] 0 0
Nijmegen
Country [38] 0 0
Netherlands
State/province [38] 0 0
Zwolle
Country [39] 0 0
Peru
State/province [39] 0 0
Lima
Country [40] 0 0
South Africa
State/province [40] 0 0
Cape Town
Country [41] 0 0
Spain
State/province [41] 0 0
Cadiz
Country [42] 0 0
Spain
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Jaen
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Spain
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Madrid
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Spain
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Malaga
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Spain
State/province [45] 0 0
Valencia
Country [46] 0 0
Switzerland
State/province [46] 0 0
Bern
Country [47] 0 0
Switzerland
State/province [47] 0 0
Mendrisio
Country [48] 0 0
Switzerland
State/province [48] 0 0
St. Gallen
Country [49] 0 0
Switzerland
State/province [49] 0 0
Thun
Country [50] 0 0
Switzerland
State/province [50] 0 0
Zurich

Funding & Sponsors
Primary sponsor type
Other
Name
ETOP IBCSG Partners Foundation
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
NSABP Foundation Inc
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00074152
Trial related presentations / publications
Wapnir IL, Aebi S, Gelber S, Anderson SJ, Lang I, Robidoux A, Mamounas EP, Wolmark N. Progress on BIG 1-02/IBCSG 27-02/NSABP B-37, a prospective randomized trial evaluating chemotherapy after local therapy for isolated locoregional recurrences of breast cancer. Ann Surg Oncol. 2008 Nov;15(11):3227-31. doi: 10.1245/s10434-008-0129-2. Epub 2008 Sep 11.
Wapnir IL, Aebi S, Geyer CE, Zahrieh D, Gelber RD, Anderson SJ, Robidoux A, Bernhard J, Maibach R, Castiglione-Gertsch M, Coates AS, Piccart MJ, Clemons MJ, Costantino JP, Wolmark N; IBCSG; BIG; NSABP. A randomized clinical trial of adjuvant chemotherapy for radically resected locoregional relapse of breast cancer: IBCSG 27-02, BIG 1-02, and NSABP B-37. Clin Breast Cancer. 2008 Jun;8(3):287-92. doi: 10.3816/CBC.2008.n.035.
Aebi S, Gelber S, Anderson SJ, Lang I, Robidoux A, Martin M, Nortier JW, Paterson AH, Rimawi MF, Canada JM, Thurlimann B, Murray E, Mamounas EP, Geyer CE Jr, Price KN, Coates AS, Gelber RD, Rastogi P, Wolmark N, Wapnir IL; CALOR investigators. Chemotherapy for isolated locoregional recurrence of breast cancer (CALOR): a randomised trial. Lancet Oncol. 2014 Feb;15(2):156-63. doi: 10.1016/S1470-2045(13)70589-8. Epub 2014 Jan 16.
Wapnir IL, Price KN, Anderson SJ, Robidoux A, Martin M, Nortier JWR, Paterson AHG, Rimawi MF, Lang I, Baena-Canada JM, Thurlimann B, Mamounas EP, Geyer CE Jr, Gelber S, Coates AS, Gelber RD, Rastogi P, Regan MM, Wolmark N, Aebi S; International Breast Cancer Study Group; NRG Oncology, GEICAM Spanish Breast Cancer Group, BOOG Dutch Breast Cancer Trialists' Group; Breast International Group. Efficacy of Chemotherapy for ER-Negative and ER-Positive Isolated Locoregional Recurrence of Breast Cancer: Final Analysis of the CALOR Trial. J Clin Oncol. 2018 Apr 10;36(11):1073-1079. doi: 10.1200/JCO.2017.76.5719. Epub 2018 Feb 14.
Public notes

Contacts
Principal investigator
Name 0 0
Stefan Aebi, MD
Address 0 0
Inselspital Bern, Switzerland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00074152