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A Randomized Phase III Trial Comparing 16 to 18 Weeks of Neoadjuvant Exemestane (25 mg Daily), Letrozole (2.5 mg), or Anastrozole (1 mg) in Postmenopausal Women With Clinical Stage II and III Estrogen Receptor Positive Breast Cancer


Phase 2/Phase 3
65 Years
N/A
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

A Randomized Phase III Trial Comparing 16 to 18 Weeks of Neoadjuvant Exemestane (25 mg Daily), Letrozole (2.5 mg), or Anastrozole (1 mg) in Postmenopausal Women With Clinical Stage II and III Estrogen Receptor Positive Breast Cancer

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinical response (complete or partial response) rate at baseline and week 16

Outcome Time Frame:

16-18 weeks with periodic follow-up over a ten year period

Safety Issue:

No

Principal Investigator

Matthew J. Ellis,, MB, PhD, FRCP

Investigator Role:

Study Chair

Investigator Affiliation:

Washington University in St. Louis, Missouri

Authority:

United States: Food and Drug Administration

Study ID:

0120070323

NCT ID:

NCT00698971

Start Date:

January 2006

Completion Date:

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

Name

Location

University of Medicine and Dentistry of New JerseyNewark, New Jersey  07103-2425