Description:
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.
Title
- Brief Title: CONcurrent vs SEqueNTial Adjuvant Treatments in Early Breast Cancer
- 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.
Clinical Trial IDs
- ORG STUDY ID:
GIM10-CONSENT
- SECONDARY ID:
2013-001629-23
- NCT ID:
NCT02918084
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| Anastrozole or Letrozole or Exemestane | Clinical Practice | ARM A |
| Anastrozole or Letrozole or Exemestane | Experimental arm | ARM B |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| ARM A | Sham Comparator | Adjuvant chemotherapy → Aromatase inhibitors x 5 yrs (sequential arm) | - Anastrozole or Letrozole or Exemestane
|
| ARM B | Experimental | Adjuvant chemotherapy + Aromatase inhibitors x 5 yrs (concurrent arm) | - Anastrozole or Letrozole or Exemestane
|
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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | Female |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Disease- free Survival (DFS) |
| Time Frame: | up to 15 years |
| Safety Issue: | |
| Description: | 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 Outcome Measures
| Measure: | Overall Survival (OS) |
| Time Frame: | time between the date of randomization up to the date of death for any cause, assessed up to 15 years. |
| Safety Issue: | |
| Description: | |
| Measure: | Translational Study: genomic analysis |
| Time Frame: | up to 15 years |
| Safety Issue: | |
| Description: | Expression of genes associated with ER and Ki67 expression will be analyzed by Real Time polymerase chain reaction (PCR) on RNA extracted from formalin-fixed paraffin embedded (FFPE) sections of tumors classified as intermediate risk by clinical and pathological variables (stage I-II, G2, hormone receptors positive) and will be correlated with disease free survival. |
| Measure: | Translational Study: epigenetic analysis |
| Time Frame: | up to 15 years |
| Safety Issue: | |
| Description: | miRNA expression analysis by real time PCR and DNA methylation analysis by pyrosequencing will be assessed on FFPE sections of tumors classified as intermediate risk by clinical and pathological variables (stage I-II, G2, hormone receptors positive) |
| Measure: | Translational Study: proteomic analysis |
| Time Frame: | up to 15 years |
| Safety Issue: | |
| Description: | The different proteomic profiles identified in FFPE sections of hormone receptors positive G2 tumors will be correlated with DFS |
Details
| Phase: | Phase 3 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy |
Trial Keywords
- sequential administration chemiotherapy
- early breast cancer
- breast cancer
- aromatase inhibitor
- adjuvant
- post menopausal
Last Updated
November 16, 2020
