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.
Overview
- Phase
- Phase 3
- Intervention
- Anastrozole or Letrozole or Exemestane
- Conditions
- Breast Cancer
- Sponsor
- IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
- Enrollment
- 1000
- Locations
- 74
- Primary Endpoint
- Disease- free Survival (DFS)
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
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.
Investigators
Lucia Del Mastro,MD
Director of S.S. Innovative Therapies Unit
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
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:
- •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
- •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).
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
Arms & Interventions
ARM A
Adjuvant chemotherapy → Aromatase inhibitors x 5 yrs (sequential arm)
Intervention: Anastrozole or Letrozole or Exemestane
ARM B
Adjuvant chemotherapy + Aromatase inhibitors x 5 yrs (concurrent arm)
Intervention: Anastrozole or Letrozole or Exemestane
Outcomes
Primary Outcomes
Disease- free Survival (DFS)
Time Frame: up to 15 years
the primary outcome indicator will be the so called DFS, defined as time elapsing between the date of randomization and the date of one of the following events, whichever occurs first, assessed up to 15 years: * Local Recurrence of disease * Regional recurrence of disease * Distant recurrence of disease * Contralateral invasive or intraductal breast cancer * Second primary malignancy other than breast * Death for any cause
Secondary Outcomes
- Translational Study: genomic analysis(up to 15 years)
- Overall Survival (OS)(time between the date of randomization up to the date of death for any cause, assessed up to 15 years.)
- Translational Study: epigenetic analysis(up to 15 years)
- Translational Study: proteomic analysis(up to 15 years)