Tamoxifen or Letrozole in Treating Women With Ductal Carcinoma in Situ

NCT00290745 | Completed Phase 1 Results DMC FDA Drug

• 4 other identifiers: 017513UCSF-H10367-19435-05NCI-2011-01273CDR0000465205
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

breast cancer in situ; ductal breast carcinoma in situ

Outcome Measures

Primary Outcomes (2)

• Median Change in 6-month Tumor Volume Compared to Baseline Using Mammography

  Change in size of Ductal Carcinoma in situ (DCIS) for participants on hormonal therapy, as determined by mammography are determined by (1) largest diameter of tumor, as visualized on mammography (2) extent of disease on mammography (3) quantification of mammographically-detected change from baseline to 6-month and used to generate the change in tumor volume of mammographic extent of disease from baseline. Since values were not normally distributed, the median change was calculated, and Wilcoxon sign rank tests were used to evaluate the significance of these changes

  Baseline and 6 months

• Median Change in 6-month Tumor Volume Compared to Baseline Using Magnetic Resonance Imaging (MRI)

  Change in size of Ductal Carcinoma in situ (DCIS) on hormonal therapy, as determined by MRI are determined by (1) largest diameter of tumor, as visualized on MRI (2) extent of disease on MRI (3) quantification of MR-detected change from baseline to 6-month and used to generate the change in tumor volume of MRI extent of disease from baseline. Since values were not normally distributed, the median change was calculated, and Wilcoxon sign rank tests were used to evaluate the significance of these changes.

  Baseline and 6 months

Secondary Outcomes (7)

• Number of Responders to Neoadjuvant Therapy at Month 3

  3 months

• Number of Responders to Neoadjuvant Therapy at Month 6

  6 months

• Median Reduction in Tumor Volume by Estrogen Receptor Hormone (ER H-) Quartile Group

  Baseline and 6 months

• Median Reduction in Tumor Volume by PgR H-score by Quartile Group

  Baseline and 6 months

• Median Reduction in Tumor Volume by Ki-67 Average Score

  Baseline and 6 months

Study Arms (1)

tamoxifen or letrozole

EXPERIMENTAL

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

Drug: letrozole; Drug: tamoxifen citrate; Procedure: conventional surgery; Procedure: neoadjuvant therapy

Interventions

letrozole DRUG

tamoxifen or letrozole

tamoxifen citrate DRUG

tamoxifen or letrozole

conventional surgery PROCEDURE

tamoxifen or letrozole

neoadjuvant therapy PROCEDURE

tamoxifen or letrozole

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Novartis: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (2)

• 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.

  PMID: 19689789 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Breast Carcinoma In Situ; Carcinoma, Intraductal, Noninfiltrating

Interventions

Letrozole; Tamoxifen; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Adenocarcinoma; Neoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Combined Modality Therapy; Therapeutics

Limitations and Caveats

All good cause efforts to retrieve the serious adverse event and non-serious adverse event data have been exhausted. Adverse event data are no longer accessible per institutional and contractual guidelines and hence not available to be reported.

Results Point of Contact

• Title: Dr. E. Shelly Hwang, MD, MPH
• Organization: Duke University and Duke Cancer Institute

shelley.hwang@duke.edu

(919) 684-6849

Study Officials

• E. Shelley Hwang, MD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Frederic M. Waldman, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Nola M. Hylton, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Rita Mukhtar, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2006
• First Posted: February 13, 2006
• Study Start: February 19, 2002
• Primary Completion: July 31, 2009
• Study Completion: June 30, 2011
• Last Updated: December 4, 2020
• Results First Posted: December 4, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)