A RANDOMIZED PHASE 2 CLINICAL TRIAL TO EVALUATE THE ACTIVITY OF ATRA IN COMBINATION WITH ANASTROZOLE IN PRE-OPERATIVE PHASE OF OPERABLE HR-POSITIVE/HER2-NEGATIVE EARLY BREAST CANCEREBC ATRA TRIA
- Conditions
- Patients with newly, untreated, resectable HR+/HER2- eBCs, suitable for pre-operative therapy with anastrozoleMedDRA version: 20.0Level: 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
- EUCTR2018-001856-36-IT
- Lead Sponsor
- IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 112
1.Signed, informed consent
2.Histologically confirmed non-metastatic operable primary invasive HR-positive breast cancer subjected to diagnostic core biopsy
3.Menopausal status
4.HR-positive/HER2-negative eBC defined as
-ER>1% on immunohistochemistry (IHC) staining
-HER2 score equal to 0, 1+, 2+ (if FISH neg) on IHC staining
5.Available paraffin-embedded tumor block (FFPE) taken at diagnostic biopsy for Ki67 determination (IHC)
6.Adequate bone marrow, hepatic and renal function including the following
a.Hb = 9.0 g/dL, absolute neutrophil count = 1.5 x 109/L, platelets =100 x 109/L
b.Total bilirubin = 1.5 x upper normal limit, excluding cases where elevated bilirubin can be attributed to Gilberts Syndrome
c.AST (SGOT), ALT (SGPT) = 2.5 x upper normal limit (or 5x UNL in the presence of liver metastases)
d.Creatinine = 1.5 x upper normal limit
7.Age = 18 years
8.Performance status (PS) = 1 (ECOG scale).
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 51
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 61
1.Presence of metastatic disease
2.Pre-menopausal status
3.Previous investigational treatment for any condition within 4 weeks of randomization date
4.Treatment including radiation therapy, chemotherapy, biotherapy and/or hormonal therapy for the currently diagnosed breast cancer prior to study entry
5.Co-existing active infection or serious concurrent illness
6.Any medical or other condition that in the Investigator’s opinion renders the patient unsuitable for this study due to unacceptable risk
7.Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary studies
8.Gastrointestinal disorders that may interfere with absorption of the study drug.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method