CONcurrent vs SEqueNTial Adjuvant Treatments in Early Breast Cancer

What this trial studies

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.

Conditions in scope

• Breast Cancer

Interventions

• Anastrozole or Letrozole or Exemestane (Drug) — Adjuvant chemotherapy → Anastrozole or Letrozole or Exemestane once a day for 5 years (sequential arm)
• Anastrozole or Letrozole or Exemestane (Drug) — Adjuvant chemotherapy + Anastrozole or Letrozole or Exemestane once a day for 5 years (concurrent arm)

Who can join

Women only · Ages 18 Years and up

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)

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

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Showing the first 10 of 74 sites. See all sites on ClinicalTrials.gov.

Status & timeline

• Overall status: Active, not recruiting
• Study type: Interventional
• Phase: PHASE3
• Start date: 2013-06
• Primary completion: 2028-06
• Last update posted: 2026-05-06
• First posted: 2016-09-28

Sponsor & contact

Lead sponsor: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy (Other)

Collaborators: Clinical Research Technology S.r.l.

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Disease- free Survival (DFS) (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…

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.