KCT0002936Completed未知
A phase II study investigating preoperative combination strategies for immunotherapy in patients with untreated, operable ER+, HER2-negative primary breast cancer
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Asan Medical Center
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional Study
Eligibility Criteria
- Ages
- 19(Year) to 0No Limit (—)
- Sex
- Female
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
- •b. Non-Luminal B breast cancer
- •9. Adequate haematologic and end-organ function within 28 days prior to the first study treatment defined by the following:
- •a. ANC = 1500 cells/µL (1.5 x 109/L) (without granulocyte colony-stimulating factor support within 2 weeks prior to Cycle 1, Day 1)
- •b. WBC > 2500/µL (2.5 x 109/L)
- •c. Platelet count = 100,000/µL (100 x 109/L) (without transfusion within 2 weeks prior to Cycle 1, Day 1)
- •d. Haemoglobin = 9.0 g/dL (90g/L) (patients may be transfused or receive erythropoietic treatment to meet this criterion).
- •e. Serum albumin = 3g/dL
- •f. AST or ALT and ALP < 2.5 times the institutional upper limit of normal (ULN), bilirubin = 1.5 x ULN (patients with known Gilbert disease who have serum bilirubin level = 3 × the institutional ULN may be enrolled).
- •g. Creatinine = 1.5 x ULN
- •h. INR and aPTT = 1.5 × the institutional ULN. This applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose.
- •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, (see section 6.12) beginning 14 days before the first dose of study drug and for 6 months after the last dose of study drug.
- •11. Ability to comply with the protocol
- •12. Representative formalin-fixed paraffin embedded (FFPE) breast tumour samples with an associated pathology report that are determined to be available and sufficient for central testing OR tumour accessible for biopsy.
Exclusion Criteria
- •1. Inflammatory breast cancer
- •2. Concurrent use of HRT (HRT users must stop HRT a minimum of 28 days before the baseline diagnostic biopsy is taken).
- •3. 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.
- •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-programmed death-1 (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 (i.e. for adrenal insufficiency) and mineralocorticoids (e.g. fludrocortisone) is allowed.
- •8. 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).
- •9. Administration of a live, attenuated vaccine (e.g., FluMist®) within 28 days prior to randomisation, treatment, or within 5 months following the last dose of atezolizumab.
- •10. Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin [IL] -2) within 28days or five half-lives of the drug, whichever is shorter, prior to enrolment.
- •11. History of autoimmune disease including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjögren’s syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. Patients with autoimmune-related hypothyroidism on a stable dose of thyroid replacement therapy may be eligible for the study following discussion with the medical monitor (See Appendix 1 for complete list).
- •12. History of idiopathic pulmonary fibrosis (including pneumonitis or interstitial lung disease), drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest CT scan (History of radiation pneumonitis in the radiation field (fibrosis) is permitted).
- •13. History of HIV infection
- •14. Known active hepatitis infection (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C. Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen [anti-HBc] antibody test) are eligible. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.
- •15. Active tuberculosis
- •16. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- •17. Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation.
- •18. Any other disease, metab
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