THE OPTIMAL TIMING FOR ADMINISTRATION OF CHEMOTHERAPY AND AROMATASE INHIBITORS IN EARLY BREAST CANCER PATIENTS.

Conditions: Breast cancer is the most common form of cancer among women in North America, Europe and Latin America. Beacause nearly 80% of breast cancers are endocrine-responsive tumors, the majority of patients candidates for adjuvant chemotherapy (CT) are also candidates for endocrine therapy (ET).The optimal timing (i.e. concomitant vs sequential administration) for the integration of these two treatments has not been clearly defined yet.
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2013-001629-23-IT

Lead Sponsor: IRCCS AOU SAN MARTINO- IST

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: Not specified

Inclusion Criteria

- Women with histological diagnosis of invasive breast cancer completely removed by surgery, any T, any N.
- Postmenopausal status defined by at least one of the following conditions:
1. Aged = 60
2. Aged 45-59 and satisfying one or more of the following criteria
• amenorrhea for =12 months and intact uterus;
• amenorrhea for <12 months and FSH within the
postmenopausal range, including:
?? pts with hysterectomy
?? pts who have received HRT
?? pts with chemotherapy-induced amenorrhea
3. bilateral oophorectomy at any age >18 years.
- Primary tumor positive for ER and/or PgR (=1% tumor cells positive by
immunohistochemistry or = 10 fmol/mg cytosol protein by ligand binding assay).
- Patients who are prescribed 5 years of endocrine therapy with an AI
- Indication for adjuvant chemotherapy- Patients with HER-2 positive tumors are eligible provided that they are prescribed
trastuzumab according to registered schedule.
- Signed informed consent.

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 1200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 600

Exclusion Criteria

- HRT currently assumed or during the month before randomization
- Recurrent or metastatic disease
- HER-2 positive tumors if treatment with trastuzumab is considered not appropriate/feasible
- Concurrent illness that contraindicate adjuvant endocrine treatment and/or chemotherapy
- Patients who have received TAM as part of any breast cancer prevention trial
- Previous history of invasive breast cancer or other invasive malignancy within
the previous 10 years, other than squamous or basal cell carcinoma of the skin
or carcinoma in situ of the cervix, adequately cone biopsied
- Concomitant severe disease which would place the patient at unusual risk
- Concurrent treatment with experimental drugs
- Patients treated with systemic investigational drugs within the past 30 days