JPRN-jRCTs021210010
Recruiting
Phase 2
A phase II study of combination of radiotherapy and Atezolizumab/nab-paclitaxel for inoperable or recurrent PD-L1 positive triple negative breast cancer - IMRad-Br
Suzuki Yoshiyuki0 sites20 target enrollmentJune 4, 2021
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- inoperable or recurrent PD-L1 positive triple negative breast cancer
- Sponsor
- Suzuki Yoshiyuki
- Enrollment
- 20
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(1\) Written informed consent has been obtained from the patient himself / herself.
- •(2\) Age 20 years / over
- •(3\) Histologically confirmed inoperable or recurrent triple\-negative breast cancer (without HER2, ER, PR expression, with PD\-L1 expression).
- •\-HER2\-negative is evaluated in the each institution according to one of the following definitions.
- •\-No amplification in in situ hybridization (ISH), or IHC 0 or IHC 1\+
- •\-ER and PR negative are defined as less than 10% of hormone receptor\-expressing cells in IHC analysis.
- •\-PD\-L1 positive means that the PD\-L1 score in the tumor tissue is IC 1 or higher in the IHC analysis using the SP142 antibody.
- •(4\) Within 2 regimens of chemotherapy or systemic targeted therapy for the breast cancer
- •(5\) ECOG Performance Status 0\-2
- •(6\) Patients who can be expected to survive for 12 weeks or more
Exclusion Criteria
- •1\) V20 (ratio of lung volume irradiated above 20 Gy to total lung volume) is expected to exceed 20%
- •2\) Heterozygous / synchronous double cancer (excluding cervical carcinoma in situ, well\-treated basal cell carcinoma of the skin, intramucosal cancer of the digestive tract, and malignant tumors treated more than 5 years ago without recurrence)
- •3\) Patients with a history of hypersensitivity to the ingredients of atezolizumab preparations, patients with a history of hypersensitivity to Nab\-paclitaxel or additives. And, have a history of high hypersensitivity reaction to other antibody preparations (if it develops before 2 years and there is no recurrence, it can be registered).
- •4\) Receive continuous systemic administration (oral or intravenous) of steroids or other immunosuppressive drugs. However, temporary use or use of low doses of prednisolone or prednisolone equivalent less than 15 mg / day can be registered.
- •5\) Patients with or with a history of recurrent autoimmune disease. However, it does not include the patients with hypothyroidism that can be controlled by hormone replacement therapy and skin diseases that do not require systemic management (white spots, psoriasis, alopecia, etc.).
- •6\) Have one or more of interstitial pneumonia, pulmonary fibrosis, severe emphysema diagnosed by diagnostic imaging (preferably diagnosed by CT) or clinical findings. A history of radiation pneumonitis (fibrosis) in the irradiation field is acceptable.
- •7\) Have the following serious illnesses or conditions
- •\-Significant nutritional disorders
- •\-Transient ischemic attack, cerebrovascular attack, thrombosis, or thrombotic embolism within 180 days before full registration
- •\-Congestive heart failure (NYHA Class III or IV)
Outcomes
Primary Outcomes
Not specified
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