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Randomized Phase II Trial of Anastrozole in Combination With/Without Metronomic Tegafur-uracil as Neo-adjuvant Therapy in Postmenopausal Primary Breast Cancer


Phase 2
N/A
N/A
Not Enrolling
Female
Breast Neoplasms

Thank you

Trial Information

Randomized Phase II Trial of Anastrozole in Combination With/Without Metronomic Tegafur-uracil as Neo-adjuvant Therapy in Postmenopausal Primary Breast Cancer


Inclusion Criteria:



- Histologically-confirmed diagnosis of invasive breast cancer

- Clinical stage T2, N0 or N1, M0 (TNM Classification)

- Patients must be postmenopausal

- Tumors are estrogen receptor (ER) positive and human epidermal growth factor receptor
(HER2) negative

- ECOG Performance status (PS) 0 or 1

- Patients must be able to swallow tablets and capsules

- Candidates for mastectomy or breast-conserving surgery

- Adequate bone marrow, liver and renal function

- Written informed consent was obtained from all patients before randomization.

Exclusion Criteria:

- Inoperable, bilateral or inflammatory breast cancer

- multiple carcinoma

- Personal history of invasive carcinoma

- Patients receive systemic therapy of corticosteroid

- Patients receive estrogen preparation or raloxifene

- Patients with other concurrent severe and/or uncontrolled medical disease

- Patients whom doctors judged inadequate to the enrollment of this study by other
reasons.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Response Rate (confirmed by calipers CT or MRI)

Outcome Time Frame:

six months

Safety Issue:

No

Principal Investigator

Shinzaburo Noguchi, M.D. , Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Breast and Endocrine Surgery, Osaka University Graduate School of Medicine

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

TRIBC1009

NCT ID:

NCT01262274

Start Date:

December 2010

Completion Date:

July 2013

Related Keywords:

  • Breast Neoplasms
  • Breast Neoplasms
  • Neoplasms

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