Tamoxifen or Letrozole in Treating Women With Ductal Carcinoma in Situ

University of California San Francisco (UCSF)

Status and phase

Completed

Phase 2

Phase 1

Conditions

Breast Cancer

Treatments

Procedure: conventional surgery

Drug: letrozole

Procedure: neoadjuvant therapy

Drug: tamoxifen citrate

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00290745

UCSF-H10367-19435-05 (Other Identifier)

NCI-2011-01273 (Registry Identifier)

CDR0000465205 (Other Identifier)

017513

Details and patient eligibility

About

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.

Full 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.

Enrollment

79 patients

Sex

Female

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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