Feasibility of Pre-Surgical Intervention Studies for Evaluating Targeted Therapies for Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Avon Foundation
Information provided by (Responsible Party):
Katherine D. Crew, Columbia University
ClinicalTrials.gov Identifier:
NCT01004744
First received: October 28, 2009
Last updated: February 11, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Invasive Breast Cancer
Drug: Anastrozole

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility of Pre-Surgical Intervention Studies for Evaluating Targeted Therapies for Breast Cancer

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Feasibility of a short-term administration of a targeted therapy in the interval between their breast biopsy and surgery [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: February 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Presurgical anastrozole
1mg PO daily for two weeks prior to surgery
Drug: Anastrozole
1mg PO daily for two weeks prior to scheduled surgery

Detailed Description:

Several clinical models are being explored for use in the phase I/II evaluation of targeted therapies for breast cancer. Biological markers can be measured in early stage invasive cancers in a presurgical model involving a short term intervention. In this model, women with newly diagnosed early invasive breast cancer receive a study drug during the interval between diagnostic breast biopsy and surgical resection. Tumor tissue obtained from the biopsy and surgical specimens are used to measure pre and post treatment molecular markers, respectively. The main advantages of this model include the ability to obtain direct information on molecular response in tumor tissue and elucidate drug mechanisms of action, the large patient population to draw from with early stage breast cancer, and the lack of unnecessary invasive procedures.

We plan to conduct a pilot study of 10 postmenopausal women with newly diagnosed estrogen receptor (ER)positive invasive or non invasive breast cancer who will receive oral anastrozole 1mg daily for two weeks in the interval between diagnostic breast biopsy and definitive breast surgery. Patients will be identified by the breast surgeon or mammographer performing the breast biopsy. Patients with histologically confirmed ER+ invasive or non invasive breast cancer will be recruited by the medical oncologist and will start anastrozole two weeks prior to their scheduled surgery. The primary objective of this study is to demonstrate the feasibility of this presurgical model for evaluating targeted therapies for breast cancer. Secondary endpoints include changes in tissue levels of the proliferation marker Ki67 and proteins involved in PI3K/AKT signaling.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Treatment with other investigational drugs within 6 months of study entry
  • Other serious intercurrent medical illness
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01004744

Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Avon Foundation
Investigators
Principal Investigator: Katherine Crew, MD Columbia University
  More Information

No publications provided

Responsible Party: Katherine D. Crew, Assistant Professor of Medicine and Assistant Professor of Epidemiology, Columbia University
ClinicalTrials.gov Identifier: NCT01004744     History of Changes
Other Study ID Numbers: AAAC0553
Study First Received: October 28, 2009
Last Updated: February 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
Postmenopausal women
ER+
Estrogen positive
PR+
Progesterone positive

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Anastrozole
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014