A Phase I/II Study of Paclitaxel plus Carboplatin and Durvalumab (MEDI4736) with or without Oleclumab (MEDI9447) for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer - SYNERGY trial

Institut Jules Bordet0 sites180 target enrollmentJune 25, 2019

ConditionsPreviously untreated locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC)MedDRA version: 20.0Level: PTClassification code 10006198Term: Breast cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10075566Term: Triple negative breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem 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: Previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC)
Sponsor: Institut Jules Bordet
Enrollment: 180
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 25, 2019

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Institut Jules Bordet

Eligibility Criteria

Inclusion Criteria

•Patients must meet all the following criteria to be eligible for the study:
•1\.Age of \= 18 years
•3\.Life expectancy of a least 12 weeks
•4\.Body weight above 35kg
•5\.The locally recurrent or metastatic relapse must be histologically confirmed TNBC in patients not previously treated with systemic treatment and which cannot be treated with curative intent. Newly diagnosed patients with de\-novo metastatic disease are eligible
•6\.Estrogen receptor (ER) and progesterone receptor (PR) negativity (\< 1% positive staining cells in the invasive tumour) determined locally using IHC per ASCO/CAP criteria58
•7\.Human epidermal growth factor receptor 2 (HER2\) negativity (negative IHC staining \[score 0 or 1] or negative fluorescence in situ hybridization \[FISH] based on the ASCO/CAP guidelines and recommendations from 2013\) and determined locally59
•Note: patients initially diagnosed with hormone receptor–positive and/or HER2\-positive breast cancer are eligible if the tumor biopsy obtained from a local recurrence or distant metastasis site confirms the TNBC disease.
•8\.Confirmed tumour PD\-L1 and CD73 IHC assessment as documented through central testing of a representative tumour tissue specimen for stratification purposes (only for phase II)
•9\.Provision of recurrence/metastatic tissue samples (at least 1 FFPE \[Formalin\-Fixed paraffin\-embedded] tumour tissue and 1 frozen core as a priority, if feasible 2 additional fresh tumour tissue cores should be collected too) including those from resections, core\-needle biopsies or excisional, incisional, punch, or forceps biopsies. Fine\-needle aspiration (FNA) (defined as samples that do not preserve tissue architecture and yield cell suspension and/or smears), brushing, and cell pellets from cytology samples are not acceptable. If the patient has just performed a metastatic lesion biopsy, the patient is eligible only if an archived FFPE tissue sample (or at least 20 unstained slides, freshly cut for the purposes of the study) of the metastatic lesion is available. In this situation only, frozen/fresh cores are not mandatory. In case of a de\-novo metastatic disease, a biopsy of the primary lesion (without a biopsy of a metastatic lesion) is acceptable (at least 1 FFPE tumour tissue and 1 frozen core as a priority, if feasible 2 additional fresh tumour tissue cores should be collected too).

Exclusion Criteria

•Patients who exhibit any of the following conditions at screening are ineligible for admission into the study:
•1\.Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g., colitis or Crohn's disease], diverticulitis \[with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion:
•a)Patients with vitiligo or alopecia
•b)Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
•c)Any chronic skin condition that does not require systemic therapy
•d)Patients without active disease in the last 5 years may be included but only after consultation with the study physician
•e)Patients with celiac disease controlled by diet alone
•2\.Current or prior treatment with immunosuppressive medication within 14 days prior to enrolment. The following are exceptions to this criterion:
•a)Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
•b)Systemic corticosteroids at physiologic doses not to exceed \< 10 mg/day of prednisone or its equivalent