Tamoxifen or Letrozole in Treating Women With Ductal Carcinoma in Situ

NCT ID: NCT00290745

Last Updated: 2020-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-02-19
• Study Completion Date: 2011-06-30

Brief Summary

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen or letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells or by lowering the amount of estrogen the body makes.

PURPOSE: This clinical trial is studying how well tamoxifen or letrozole work in treating women with ductal carcinoma in situ.

Detailed Description

OBJECTIVES:

• Determine the clinical response in women with estrogen receptor-positive ductal carcinoma in situ (DCIS) treated with neoadjuvant hormonal therapy comprising tamoxifen or letrozole, by evaluating the maximal change in tumor diameter on mammography and MRI following treatment.
• Identify those cellular antigens which are altered by hormonal therapy.
• Determine which cellular antigens are predictive of clinical response to hormonal therapy.
• Evaluate whether genomic changes or gene expression in DCIS are altered by hormonal therapy and find candidate genes which are correlated with response to treatment.

OUTLINE: This is a pilot study.

Patients who are premenopausal receive oral tamoxifen once daily for 3 months in the absence of unacceptable toxicity. Patients who are post menopausal receive oral letrozole once daily for 3 months in the absence of unacceptable toxicity.

After 3 months of hormonal therapy, patients undergo lumpectomy or mastectomy.

After completion of study treatment, patients are followed every 6 months for 5 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Conditions

Breast Cancer

Keywords

breast cancer in situ; ductal breast carcinoma in situ

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

tamoxifen or letrozole

tamoxifen or letrozole work in treating women with ductal carcinoma in situ

Group Type: EXPERIMENTAL

letrozole

Intervention Type: DRUG

tamoxifen citrate

Intervention Type: DRUG

conventional surgery

Intervention Type: PROCEDURE

neoadjuvant therapy

Intervention Type: PROCEDURE

Interventions

letrozole

Intervention Type: DRUG

tamoxifen citrate

Intervention Type: DRUG

conventional surgery

Intervention Type: PROCEDURE

neoadjuvant therapy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of ductal carcinoma in situ (DCIS) on core biopsy
• No evidence of contralateral breast disease or palpable masses on breast examination
• No presence or suspicion of invasive cancer, including contralateral invasive cancer, on core biopsy and MRI
• No documented ipsilateral axillary adenopathy
• Planning to undergo lumpectomy or mastectomy
• Estrogen receptor (ER)-positive tumor by immunohistochemistry

PATIENT CHARACTERISTICS:

• Female patient
• Premenopausal or postmenopausal

• Postmenopausal is defined by any of the following:

• No spontaneous menses for >= 1 year
• Bilateral oophorectomy
• Radiation castration and amenorrheic for >= 3 months
• Follicle-stimulating hormone (FSH) > 20 IU/L AND off all hormonal therapy (e.g., hormone replacement therapy or birth control pills) for >= 1 month
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No co-morbidities contraindicating the use of tamoxifen, including any of the following:

• Prior history of thrombotic events
• History of hypercoagulable state
• History of endometrial hyperplasia
• Abnormal vaginal bleeding
• No history of contrast dye-related allergies/reactions
• No history of metal-containing prostheses or implants

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

E. Shelley Hwang, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Frederic M. Waldman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Nola M. Hylton, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Rita Mukhtar, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

References

Chen YY, DeVries S, Anderson J, Lessing J, Swain R, Chin K, Shim V, Esserman LJ, Waldman FM, Hwang ES. Pathologic and biologic response to preoperative endocrine therapy in patients with ER-positive ductal carcinoma in situ. BMC Cancer. 2009 Aug 18;9:285. doi: 10.1186/1471-2407-9-285.

Reference Type: BACKGROUND

PMID: 19689789 (View on PubMed)

Swain RS, Chen YY, Wa C, et al.: Pathologic and biologic response to neoadjuvant anti-estrogen (AE) therapy in patients with ductal carcinoma in situ (DCIS). [Abstract] United States and Canadian Academy of Pathology 95th Annual Meeting, February 11-17, 2006, Atlanta, GA. A-186, 2006.

Reference Type: BACKGROUND

Other Identifiers

UCSF-H10367-19435-05

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2011-01273

Identifier Type: REGISTRY

Identifier Source: secondary_id

CDR0000465205

Identifier Type: OTHER

Identifier Source: secondary_id

017513

Identifier Type: -

Identifier Source: org_study_id