Trial | NCT02918084  Report issue

Title

CONcurrent vs SEqueNTial Adjuvant Treatments in Early Breast Cancer
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.

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Active, not recruiting

  • Study Participants

    1000
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.
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.
Study Started
Jun 30
2013
Primary Completion
Jun 30
2028
Anticipated
Study Completion
Jun 30
2028
Anticipated
Last Update
May 24
2022

Drug Anastrozole or Letrozole or Exemestane

Adjuvant chemotherapy → Anastrozole or Letrozole or Exemestane once a day for 5 years (sequential arm)

  • Other names: Clinical Practice

Drug Anastrozole or Letrozole or Exemestane

Adjuvant chemotherapy + Anastrozole or Letrozole or Exemestane once a day for 5 years (concurrent arm)

  • Other names: Experimental arm

ARM A Sham Comparator

Adjuvant chemotherapy → Aromatase inhibitors x 5 yrs (sequential arm)

ARM B Experimental

Adjuvant chemotherapy + Aromatase inhibitors x 5 yrs (concurrent arm)

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 ≥ 60

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).
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
No Results Posted