Prolonged Tamoxifen Compared With Shorter Tamoxifen in Treating Patients Who Have Breast Cancer

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Primary Purpose

Status

Unknown status

Phase

Phase 3

Locations

United Kingdom

Study Type

Interventional

Intervention

tamoxifen citrate

adjuvant therapy

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer

Eligibility Criteria

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DISEASE CHARACTERISTICS: Curatively treated carcinoma of the breast Currently taking adjuvant tamoxifen Must be substantial uncertainty as to whether or not to continue tamoxifen (i.e., no clear indication or definite contraindication to further treatment with tamoxifen) PATIENT CHARACTERISTICS: Age: Any age Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing No contraindications to receiving tamoxifen No other serious medical problems PRIOR CONCURRENT THERAPY: Biologic therapy: Prior biologic therapy allowed Chemotherapy: Prior chemotherapy allowed Endocrine therapy: See Disease Characteristics Radiotherapy: Prior radiotherapy allowed Surgery: Prior surgery allowed

Sites / Locations

Atlas Trial Office

Outcomes

Primary Outcome Measures

Overall survival (i.e., all-cause mortality)

Secondary Outcome Measures

Specific-cause mortality

Incidence of second primary tumors

Full Information

NCT ID

NCT00003016

First Posted

November 1, 1999

Last Updated

February 6, 2009

Sponsor

University of Oxford

1. Study Identification

Unique Protocol Identification Number

NCT00003016

Brief Title

Prolonged Tamoxifen Compared With Shorter Tamoxifen in Treating Patients Who Have Breast Cancer

Official Title

Reliable Assessment of the Efficacy and Safety of Prolonging the Use of Adjuvant Tamoxifen: A Large, Simple, Randomised Study

Study Type

Interventional

2. Study Status

Record Verification Date

October 2002

Overall Recruitment Status

Unknown status

Study Start Date

October 1995 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

University of Oxford

4. Oversight

5. Study Description

Brief Summary

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by reducing the production of estrogen. It is not yet known if prolonged tamoxifen is more effective than shorter tamoxifen therapy following curative treatment for breast cancer. PURPOSE: This randomized phase III trial is studying giving tamoxifen over a prolonged period of time to see how well it works compared to giving tamoxifen over a shorter period of time in treating patients who have had a breast tumor removed.

Detailed Description

OBJECTIVES: Assess the balance of risks and benefits in prolonging the duration of adjuvant tamoxifen by at least 5 years in patients with curatively treated breast cancer who have already had about 5 years of adjuvant tamoxifen. OUTLINE: This is a randomized study. After about 5 years of adjuvant tamoxifen, recurrence-free patients are randomized to stop tamoxifen treatment immediately or to continue tamoxifen treatment for at least 5 more years. Patients are followed annually. PROJECTED ACCRUAL: Approximately 20,000 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Allocation

Randomized

Enrollment

20000 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

tamoxifen citrate

Intervention Type

Procedure

Intervention Name(s)

adjuvant therapy

Primary Outcome Measure Information:

Title

Overall survival (i.e., all-cause mortality)

Secondary Outcome Measure Information:

Title

Specific-cause mortality

Title

Incidence of second primary tumors

10. Eligibility

Sex

All

Accepts Healthy Volunteers

No

Eligibility Criteria

DISEASE CHARACTERISTICS: Curatively treated carcinoma of the breast Currently taking adjuvant tamoxifen Must be substantial uncertainty as to whether or not to continue tamoxifen (i.e., no clear indication or definite contraindication to further treatment with tamoxifen) PATIENT CHARACTERISTICS: Age: Any age Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing No contraindications to receiving tamoxifen No other serious medical problems PRIOR CONCURRENT THERAPY: Biologic therapy: Prior biologic therapy allowed Chemotherapy: Prior chemotherapy allowed Endocrine therapy: See Disease Characteristics Radiotherapy: Prior radiotherapy allowed Surgery: Prior surgery allowed

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rodrigo Arriagada, MD

Organizational Affiliation

Karolinska Institutet

Official's Role

Study Chair

Facility Information:

Facility Name

Atlas Trial Office

City

Oxford

State/Province

England

ZIP/Postal Code

OX2 6HE

Country

United Kingdom

Breast Cancer

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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