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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
EU CTIS ID: 2024-519087-41-00
What this study is testing
To evaluate the relative efficacy of sequential as compared to concurrent administration of chemotherapy and aromatase inhibitors in patients with early breast cancer in the prevention of disease recurrence.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- - 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 FSH within the postmenopausal range, including: > pts with hysterectomy > pts who have received HRT > pts with chemotherapy-induced amenorrhea 3. bilateral oophorectomy at any age >18 years. - Primary tumor positive for ER and/or 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 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.
You likely can't join if
- - 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 TAM 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.