Official Title
A Phase III Study Comparing the Concurrent Versus the Sequential Administration of Chemotherapy and Aromatase Inhibitors, as Adjuvant Treatment of Post-menopausal Patients With Endocrine-responsive Early Breast Cancer.
Brief Title
CONcurrent vs SEqueNTial Adjuvant Treatments in Early Breast Cancer
Protocol ID
NCT02918084
Lead Sponsor
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Brief Summary
Breast cancer is the most common form of cancer among women. For patients candidated for
adjuvant chemotherapy and endocrine therapy the optimal timing for their has not been
clearly defined yet.
Detailed Description
Breast cancer is the most common form of cancer among women in North America, Europe and
Latin America. Because 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.
In patients with hormone receptor positive early stage breast cancer who are candidates
to adjuvant chemotherapy and endocrine therapy, the optimal timing for the integration of
these two treatment modalities has not been clearly defined yet.
Enrollment Count
1,000 participants
Eligibility Criteria
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 follicle-stimulating hormone (FSH) within
the postmenopausal range, including:
- pts with hysterectomy
- pts who have received hormone replacement therapy (HRT)
- pts with chemotherapy-induced amenorrhea
3. bilateral oophorectomy at any age >18 years.
- Primary tumor positive for Estrogen Receptors (ER) and/or Progesteron receptors
(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 aromatase
inhibitors (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.
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 Tamoxifen 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
Filters
Breast Cancer
PHASE3
ACTIVE_NOT_RECRUITING
ADULT
OLDER_ADULT