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


N/A
21 Years
N/A
Not Enrolling
Female
Invasive Breast Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Feasibility of a short-term administration of a targeted therapy in the interval between their breast biopsy and surgery

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Katherine Crew, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Columbia University

Authority:

United States: Institutional Review Board

Study ID:

AAAC0553

NCT ID:

NCT01004744

Start Date:

February 2007

Completion Date:

March 2008

Related Keywords:

  • Invasive Breast Cancer
  • Postmenopausal women
  • ER+
  • Estrogen positive
  • PR+
  • Progesterone positive
  • Breast Neoplasms

Name

Location

Columbia University Medical CenterNew York, New York  10032