Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III, Phase II Treatment Active 65 and over Other 0120070323 NCT00698971

Trial Description

Summary

Researchers have been studying breast cancer to learn the best way to treat the disease. Chemotherapy (treatment with anti-cancer drugs) is commonly given before surgery to shrink breast tumors. Research has shown that reducing the amount of the hormone estrogen that gets to the cancer in postmenopausal women with hormone-dependent breast cancer can shrink the breast tumor before surgery.

In this research study 3 drugs called hormone therapy (a drug used to lower the level of the hormone estrogen) will be tested. The hormone therapies being tested in this study are exemestane, anastrozole, letrozole.

The purpose of this study is to find out whether it is better to receive exemestane, anastrozole, or letrozole to improve the chance that the breast cancer will get smaller before surgery.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of breast cancer

-T2-T4c, any N, M0 disease

• Clinically staged, as documented by the operating surgeon, as 1 of the following:

• T4a-c disease for which modified radical mastectomy with negative margins is the goal

• T2 or T3 disease for which conversion from needing mastectomy to breast conservation is the goal

• T2 disease for which lumpectomy at first attempt is the goal

• Primary tumor must be palpable and measure 2 cm by caliper measurements in at least one dimension

• Must agree to undergo mastectomy or lumpectomy after neoadjuvant aromatase inhibitor therapy

• No inflammatory breast cancer, defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion (not direct skin invasion by tumor or peau d'orange without erythema)

• No distant metastasis (M1)

-Isolated ipsilateral supraclavicular node involvement allowed

• Must have estrogen receptor (ER) positive tumor with an Allred score of 6, 7 or 8

PATIENT CHARACTERISTICS:

• ECOG/Zubrod performance status of ≤ 2

• Female

• Patient must be postmenopausal, verified by 1 of the following:

• Bilateral surgical oophorectomy

• No spontaneous menses > 1 year

• No menses for < 1 year with FSH and estradiol levels in postmenopausal range

• If patient is a cancer survivor, all of the following criteria must be met:

• Must have undergone potentially curative therapy for all prior malignancies

• No evidence of any prior malignancies for at least 5 years with no evidence of recurrence (except for successfully treated cervical carcinoma in situ, lobular carcinoma in situ of the breast, or non-melanoma skin cancer with no evidence of recurrence)

• Deemed by their treating physician to be at low risk for recurrence

PRIOR CONCURRENT THERAPY:

• Any agent with estrogenic or putatively estrogenic properties, including herbal preparations, must be stopped at least one week prior to registration

• No prior treatment for breast cancer, including radiation, endocrine therapy, chemotherapy, or investigational agent

• No concurrent enrollment in another neoadjuvant clinical trial for treatment of the existing breast cancer

• No hormone replacement therapy of any type, megestrol acetate, or raloxifene within one week prior to registration

• No other concurrent anti-neoplastic approach such as chemotherapy or radiation therapy

• Concomitant use of agents and herbal products that alter ER function are specifically not allowed

Trial Contact Information

Trial Lead Organizations/Sponsors

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

Matthew J. Ellis

Study Chair

Robert Wieder, MD, PHD		Ph: 9739724871
		Email: WIEDERRO@UMDNJ.EDU

Yasmeen S Barber, BA		Ph: 9739727789
		Email: barberys@UMDNJ.EDU

U.S.A.
New Jersey
	Newark
	UMDNJ University Hospital
		Yasmeen S Barber, BA	Ph: 973-972-7789
			Email: barberys@umdnj.edu
		Robert Wieder	Principal Investigator
		Lillian F. Pliner	Sub-Investigator
		Margarette Bryan	Sub-Investigator
		Kevin Clarke, MD	Sub-Investigator
		Meera Hameed, MD	Sub-Investigator
		Dolly Razdan, MD	Sub-Investigator
		Charles S. Cathcart	Sub-Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00698971
Information obtained from ClinicalTrials.gov on August 07, 2008