Breast-Conserving Therapy Compared With Mastectomy Followed By Radiation Therapy in Treating Women With Locally Advanced Breast Cancer Previously Treated With Chemotherapy

NCT ID: NCT00028704

Last Updated: 2012-07-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-10-31

Brief Summary

RATIONALE: Breast-conserving treatments such as radiation therapy or limited surgery are less invasive than mastectomy and may improve the quality of life. It is not yet known if breast-conserving treatments are as effective as mastectomy followed by radiation therapy in treating locally advanced breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of breast-conserving therapy with mastectomy followed by radiation therapy in treating women who have locally advanced breast cancer that has been previously treated with chemotherapy.

Detailed Description

OBJECTIVES:

• Compare the overall survival and time to loco-regional failure in women with locally advanced breast cancer treated with breast-conserving local therapy vs mastectomy followed by radiotherapy after they have received prior induction chemotherapy.
• Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, initial stage (T0, T1, T2, T3, or Tx vs T4), response to prior induction chemotherapy (complete response (CR) vs other), and menopausal status (premenopausal vs postmenopausal). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients undergo mastectomy followed by radiotherapy.
• Arm II: Patients receive breast-conserving treatment comprising 1 of 3 of the following therapeutic options:

• Regimen A: Patients receive radiotherapy alone.
• Regimen B: Patients with a partial response (PR) to prior induction chemotherapy undergo limited surgery followed by radiotherapy. Patients with a CR to prior induction chemotherapy undergo radiotherapy alone.
• Regimen C: Patients with a partial response (PR) or CR to prior induction chemotherapy undergo radiotherapy alone.

Patients with a CR to radiotherapy receive no further treatment. Patients with a PR to radiotherapy undergo limited surgery.

Quality of life is assessed at baseline, at the end of therapy, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Patients are followed within 1 month, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 1,300 patients (650 per treatment arm) will be accrued for this study within 5 years.

Conditions

Breast Cancer

Keywords

stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; inflammatory breast cancer

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

conventional surgery

Intervention Type: PROCEDURE

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed locally advanced breast cancer

• T3 inoperable, N0-N2
• Any T, N2
• T4, N0-N2
• Inflammatory breast carcinoma
• Prior treatment with 4-6 courses of standard induction chemotherapy or active investigational regimens completed within the past 4 weeks
• Residual tumor size less than 5 cm
• No fixed axillary lymph nodes
• No multifocal or bilateral breast cancer
• No clinical suspicion of extensive ductal carcinoma in situ
• No unresolved skin edema
• No distant metastases (including ipsilateral supraclavicular node)

• Positive bone scan allowed provided there are no bone metastases on x-ray
• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age:

• Any age

Sex:

• Female

Menopausal status:

• Not specified

Performance status:

• WHO 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Neutrophil count at least 2,000/mm^3
• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin less than 1.5 times normal
• SGOT and SGPT no greater than 2 times normal
• Alkaline phosphatase no greater than 2 times normal

Renal:

• Creatinine less than 1.5 times normal

Other:

• No other prior or concurrent malignancy except adequately treated squamous cell or basal cell skin cancer or adequately treated cone-biopsied carcinoma in situ of the cervix
• No serious underlying medical illness that would preclude study
• No psychiatric or addictive disorder that would preclude study
• No contraindication to study treatment
• Not pregnant
• Fertile patients must use effective barrier contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics

Endocrine therapy:

• No concurrent hormonal replacement therapy
• No concurrent oral contraceptives

Radiotherapy:

• See Disease Characteristics
• No prior radiotherapy for breast cancer

Surgery:

• No prior surgery for breast cancer other than biopsy for diagnosis confirmation

Other:

• No other prior systemic therapy for breast cancer

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Central and Eastern European Oncology Group

OTHER

Sponsor Role: collaborator

Grupo Oncologico Cooperativo Chileno de Investigation

NETWORK

Sponsor Role: collaborator

International Collaborative Cancer Group

OTHER

Sponsor Role: collaborator

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacek Jassem, MD, PhD

Role: STUDY_CHAIR

Medical University of Gdansk

G. van Tienhoven, MD, PhD

Role: STUDY_CHAIR

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Marzena Welnicka-Jaskiewicz, MD

Role: STUDY_CHAIR

Medical University of Gdansk

Rodrigo Arriagada, MD

Role: STUDY_CHAIR

Instituto de Radiomedicina

Marie Emson, BSc

Role: STUDY_CHAIR

International Collaborative Cancer Group

Locations

Centre Hospitalier Etterbeek Ixelles

Brussels, , Belgium

U.Z. Gasthuisberg

Leuven, , Belgium

Instituto de Radiomedicina

Santiago, , Chile

Rambam Medical Center

Haifa, , Israel

Akademisch Medisch Centrum

Amsterdam, , Netherlands

Arnhems Radiotherapeutisch Instituut

Arnhem, , Netherlands

Leiden University Medical Center

Leiden, , Netherlands

Dr. Bernard Verbeeten Instituut

Tilburg, , Netherlands

Medical University of Gdansk

Gdansk, , Poland

Karol Marcinkowski University

Poznan, , Poland

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

Warsaw, , Poland

Hospitais da Universidade de Coimbra (HUC)

Coimbra, , Portugal

Charing Cross Hospital

London, England, United Kingdom

Countries

Belgium; Chile; Israel; Netherlands; Poland; Portugal; United Kingdom

References

Sinacki M, Jassem J, van Tienhoven G. Conservative local treatment versus mastectomy after induction chemotherapy in locally advanced breast cancer: a randomised phase III study (EORTC 10974/22002, LAMANOMA)--why did this study fail? Eur J Cancer. 2005 Dec;41(18):2787-8. doi: 10.1016/j.ejca.2005.06.027. Epub 2005 Nov 7. No abstract available.

Reference Type: RESULT

PMID: 16274985 (View on PubMed)

Other Identifiers

EORTC-10974

Identifier Type: -

Identifier Source: secondary_id

CEEOG-EORTC-10974

Identifier Type: -

Identifier Source: secondary_id

EORTC-22002

Identifier Type: -

Identifier Source: secondary_id

GOCCHI-EORTC-10974

Identifier Type: -

Identifier Source: secondary_id

ICCG-EORTC-10974

Identifier Type: -

Identifier Source: secondary_id

EORTC-BIG-0002

Identifier Type: -

Identifier Source: secondary_id

LAMANOMA

Identifier Type: -

Identifier Source: secondary_id

EORTC-10974-22002

Identifier Type: -

Identifier Source: org_study_id