Chemoprevention Trial - Anastrozole in Ductal Carcinoma In Situ (DCIS) in Postmenopausal Women

NCT00256217 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: UCI 03-16 [HS# 2004-3681]2004-3681NCI-2010-00361
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Breast cancer is one of the most common cancers seriously afflicting women in the United States. Of the one million incident cases that are reported annually there are approximately 193,000 new cases of breast cancer (Greenlee, 2001). Although significant advances have been made both in early detection and treatment of breast cancer, the impact of these on reduction in mortality has been modest (Peta, 2000). Furthermore, despite data implicating diet and other environmental risk factors, no lifestyle changes have yet been shown to significantly reduce the risk of breast cancer. Therefore, chemoprevention of breast cancer is a worthwhile approach to reduce the incidence of breast cancer. There is every reason to believe that a detailed understanding of the initiation, promotion and growth of breast cancer will ultimately provide a rational strategy upon which to base prevention strategies. While the pathways of breast cancer development are not yet fully understood, a role for estrogens in breast cancer etiology has been well established. While many pathways are involved in breast cancer etiology, including loss of tumor suppressor function by p53 or BRCA1 and gain of HER2 oncogene expression, their exact role in an individual patient's cancer development may vary. Therefore, it may be advantageous to focus on a chemoprevention strategy that may have a more uniform impact on breast cancer development, such as estrogen exposure. Estrogen and its metabolites, both in the circulation and locally synthesized in the breast, are important in the pathogenesis of breast cancer. High levels of circulating estrogen in postmenopausal women have been associated with an increased risk of breast cancer (Clemons, 2001). Furthermore, local estrogen synthesis, i.e. aromatase activity, in the breast may also be important in the development of breast cancer.

Conditions

DCIS

Outcome Measures

Primary Outcomes (1)

• Number of Participants With a Change in Ki-67 Level

  Baseline and up to 4 weeks

Secondary Outcomes (3)

• Histopathological Response

  Baseline and up to 4 weeks

• To Compare Pretreatment Vascular Density With Post Treatment Vascular Density Using MRI

  Baseline and 4 weeks after anastrozole

• To Compare Pretreatment Markers of Angiogenesis With Post Treatment Marker of Angiogenesis

  Baseline and up to 4 weeks

Study Arms (1)

Anastrozole

EXPERIMENTAL

Drug: Anastrozole

Interventions

Anastrozole DRUG

1 mg. oral every day for 2 - 4 weeks

Also known as: ARIMIDEX

Anastrozole

Eligibility Criteria

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

You may qualify if:

• Patients must have suspicion of DCIS or early invasive breast cancer on mammography.
• Patients must have histologically confirmed diagnosis of DCIS or early invasive breast cancer on core biopsy for final registration.
• Patients must be over 18 years of age
• "Patients must be postmenopausal as defined by one of the following criteria:
• Prior bilateral oophorectomy OR
• \> 12 months since LMP with no prior hysterectomy OR
• a \& b not applicable AND age \>=50
• Patients must be positive for either ER or PR or both
• Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.

You may not qualify if:

• Patients must not have diagnosis of osteoporosis (T-score -2.5 according to the WHO)

Sponsors & Collaborators

• Rita Sanghvi, Mehta: lead
• AstraZeneca: collaborator

Study Sites (1)

Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Carcinoma, Intraductal, Noninfiltrating

Interventions

Anastrozole

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: UC Irvine Health / Chao Family Comprehensive Cancer Center
• Organization: UC Irvine Health / Chao Family Comprehensive Cancer Center

ucstudy@uci.edu

1-877-UC-STUDY

Study Officials

• Rita Mehta, MD

  Chao Family Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. Rita Mehta

Study Record Dates

• First Submitted: November 16, 2005
• First Posted: November 21, 2005
• Study Start: September 21, 2004
• Primary Completion: December 12, 2018
• Study Completion: December 12, 2018
• Last Updated: May 11, 2021
• Results First Posted: May 11, 2021

Record last verified: 2021-04

Locations

US (1)