EUCTR2016-004424-38-GB
Active, not recruiting
Phase 1
A phase II study investigating preoperative combination strategies for immunotherapy in patients with untreated, operable ER+, HER2-negative primary breast cancer. - ECLIPSE: Preoperative immunotherapy combinations in breast cancer
Conditionsntreated, operable ER+, HER2-negative primary breast cancer.MedDRA version: 21.1 Level: PT Classification code 10057654 Term: Breast cancer female System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- ntreated, operable ER+, HER2-negative primary breast cancer.
- Sponsor
- Queen Mary University of London
- Enrollment
- 57
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Willing and able to provide written informed consent prior to study entry
- •2\. Female \= 18 years of age
- •3\. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1
- •4\. Histologically confirmed operable primary breast cancer
- •5\. Palpable breast tumour of any size, or tumour with an ultrasound / MRI size of \= 1 cm or mammogram
- •6\. ER\+ tumours defined as tumours with \=1% of tumour cells positive for ER on IHC staining or an IHC score (Allred) of \= 3
- •7\. HER2\-negative tumours defined as 0, 1\+ or 2\+ intensity on IHC and no evidence of amplification of the HER2 gene on ISH.
- •8\. 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
- •9\. Adequate haematologic and end\-organ function within 28 days prior to the first study treatment.
- •10\. Patients of childbearing potential are eligible provided they have a negative serum or urine pregnancy test within 14 days of Day 1 Cycle 1 of study treatment, preferably as close to the first dose as possible. Patients must agree to use adequate contraception, defined as those methods with a failure rate of \< 1 % per year, beginning 14 days before the first dose of study drug and for 6 months after the last dose of study drug.
Exclusion Criteria
- •1\. Inflammatory breast cancer
- •2\. Concurrent use of HRT.
- •3\. Previous systemic or local treatment for the new primary breast cancer currently under investigation; 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\.
- •4\. Previous systemic treatment for other neoplasms within 1 year prior to randomisation.
- •5\.Patients with prior allogeneic stem cell or solid organ transplantation.
- •6\. Prior treatment with CD137 agonists, AKT inhibitors, anti\-CTLA\-4, anti\- PD\-1, or anti\-PD\-L1 therapeutic antibody or pathway\-targeting agents.
- •7\.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 and mineralocorticoids is allowed.
- •8\. Received therapeutic oral or intravenous antibiotics \<14 days prior to randomisation.
- •9\. Administration of a live, attenuated vaccine \<28 days prior to randomisation, treatment, or within 5 months following the last dose of atezolizumab.
- •10\. Treatment with systemic immunostimulatory agents \<28days or five half\-lives of the drug, whichever is shorter, prior to enrolment.
Outcomes
Primary Outcomes
Not specified
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