Pre-operative Immunotherapy Combination Strategies in Breast Cancer (NCT03395899) | Clinical Trial Compass
CompletedPhase 2
Pre-operative Immunotherapy Combination Strategies in Breast Cancer
United Kingdom71 participantsStarted 2017-12-21
Plain-language summary
International, open label, window of opportunity phase II trial that aims to evaluate the effects of immunotherapy based treatment combinations in women with untreated, histologically confirmed, operable, ER+, HER2-negative breast cancer.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Willing and able to provide written informed consent prior to study entry
✓. Female ≥ 18 years of age
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 21
✓. Histologically confirmed operable primary breast cancer
✓. Palpable breast tumour of any size, or tumour with an ultrasound / MRI size of ≥ 1 cm or mammogram
✓. ER+ tumours defined as tumours with ≥1% of tumour cells positive for ER on IHC staining or an IHC score (Allred) of ≥ 3
✓. HER2-negative tumours defined as 0, 1+ or 2+ intensity on IHC and no evidence of amplification of the HER2 gene on ISH.
✓. Patients with either: (a) Luminal B breast cancer defined as: high Ki67 defined as ≥20% and /or histological grade 3 and / or Luminal B according to PAM50 assay or (b) Non-Luminal B breast cancer
Exclusion criteria
✕. Inflammatory breast cancer
✕. Concurrent use of HRT (HRT users must stop HRT a minimum of 28 days before the baseline diagnostic biopsy is taken).
✕. Previous systemic or local treatment for the new primary breast cancer currently under investigation (including surgery, radiotherapy, cytotoxic and endocrine treatments); prior treatment for previous breast cancer or other neoplasms is allowed as long as it was completed ≥1 year prior to Day 1 Cycle 1.
✕. Previous systemic treatment for other neoplasms within 1 year prior to randomisation..
✕. Patients with prior allogeneic stem cell or solid organ transplantation.
✕. Prior treatment with CD137 agonists, AKT inhibitors, anti-CTLA-4, anti-programmed death-1 (PD-1), or anti-PD-L1 therapeutic antibody or pathway-targeting agents.
✕. Patients must not have had oral or IV steroids for 14 days prior to study entry; the use of inhaled corticosteroids, physiologic replacement doses of glucocorticoids (i.e. for adrenal insufficiency) and mineralocorticoids (e.g. fludrocortisone) is allowed.
✕. Received therapeutic oral or intravenous antibiotics within 14 days prior to randomisation (Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligible).