A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer with Recurrence Score (RS) of 25 or Less.

• Conditions: Patients with confirmed diagnosis of node positive (1-3 nodes)invasive breast carcinoma with positive hormone receptor status, and negative HER-2.; MedDRA version: 14.1Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-000174-37-ES
• Lead Sponsor: GEICAM (Fundación Grupo Español de Investigación en Cáncer de Mama)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-22
• Last Update Posted: 29 May 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 3500

Inclusion Criteria

1. Patients must have a histologically confirmed diagnosis of node positive (1-3 nodes)
invasive breast carcinoma with positive estrogen and/or progesterone receptor status,
and negative HER-2, as determined by IHC or non-amplified FISH or CISH for screening.
2. Patients will have undergone axillary staging by sentinel node biopsy or axillary lymph
node dissection (ALND). Patients must have at least one, but no more than three known
positive lymph nodes.
3. Recurrence score (RS) by Oncotype DX® must be ? 25.
4. Patients must have had either breast-conserving surgery with planned radiation therapy or total mastectomy (with or without planned postmastectomy radiation). Patients must
have clear margins.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

1. Patients must not have inflammatory breast cancer and must not have metastatic
disease. Patients with a prior diagnosis of DCIS are eligible if they received mastectomy
alone (no therapeutic radiation or endocrine therapy).
2. Patients must not have begun chemotherapy or endocrine therapy for their breast cancer prior to registration.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified