Pre-Surgical Intervention for Targeted Therapies for Breast Cancer

NCT01004744 | Completed Results DMC

• 1 other identifier: AAAC0553
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the feasibility of a short term administration of a targeted therapy (i.e., anastrozole) in women with newly diagnosed early invasive or non invasive breast cancer during the interval between their breast biopsy and surgery. Anastrozole is a form of hormonal therapy which is part of the standard treatment for hormone sensitive breast cancer in postmenopausal women. This clinical model is being used to evaluate the biologic effects of this drug on a specific molecular pathway called the PI3K/AKT signaling pathway.

Conditions

Invasive Breast Cancer

Keywords

Postmenopausal women; ER+; Estrogen positive; PR+; Progesterone positive

Outcome Measures

Primary Outcomes (1)

• Number of Subjects That Completed Oral Anastrozole 1mg Daily for Two Weeks in the Interval Between Diagnostic Breast Biopsy and Definitive Breast Surgery

  The number of subjects who complete oral anastrozole for the length of the study is analyzed. The subjects receive oral anastrozole 1mg daily for two weeks in the interval between the biopsy and the surgery.

  Two weeks

Study Arms (1)

Presurgical oral anastrozole

EXPERIMENTAL

1mg daily for two weeks in the interval between diagnostic breast biopsy and definitive breast surgery.

Drug: Anastrozole

Interventions

Anastrozole DRUG

1mg PO daily for two weeks prior to scheduled surgery

Also known as: Arimidex

Presurgical oral anastrozole

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically-confirmed operable ER+ and/or PR+ invasive breast cancer or ductal carcinoma in situ (DCIS), who undergo core needle biopsy followed by surgical excision at least 2 weeks after enrollment
• Postmenopausal status defined as cessation of menses for \>1 year or FSH \> 20 mIU/mL (within the past month)
• Age ≥ 21 years
• No prior chemotherapy, radiation therapy, or surgery within 6 months of study entry
• Signed informed consent

You may not qualify if:

• Treatment with other investigational drugs within 6 months of study entry
• Other serious intercurrent medical illness

Sponsors & Collaborators

• Columbia University: lead
• Avon Foundation: collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Interventions

Anastrozole

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Katherine Crew
• Organization: Columbia University

kd59@cumc.columbia.edu

212-305-1732

Study Officials

• Katherine Crew, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine and Assistant Professor of Epidemiology

Study Record Dates

• First Submitted: October 28, 2009
• First Posted: October 30, 2009
• Study Start: July 1, 2007
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: January 11, 2021
• Results First Posted: January 11, 2021

Record last verified: 2021-01

Locations

US (1)