JCOG2205-TN-1: Sustainable and Efficient Platform of New Therapeutic Development for Early Breast Cancer (S-FACT) Triple-negative breast cancer cohort (TN-1)

JRCT ID: jRCT2031240160

Registered date:13/06/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Clinical stage II or III, resectable breast cancer
• Date of first enrollment: 21/06/2024
• Target sample size: 100
• Study type: Interventional

Intervention(s)

Arm A:
Best available therapy for neoadjuvant therapy at this time.
Carboplatin + paclitaxel + pembrolizumab followed by doxorubicin + cyclophosphamide + pembrolizumab

Arm B:
Carboplatin + paclitaxel + pembrolizumab followed by niraparib + pembrolizumab

<Surgery>
Breast: mastectomy or breast-conserving surgery, axillary dissection in case of axillary lymph node metastasis

Outcome(s)

• Primary Outcome: Pathological complete response, proportion of ctDNA clearance
• Secondary Outcome: Adverse event rate

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

Eligibility Criteria of master protocol
(1) Histologically diagnosed as invasive breast cancer and intrinsic subtype was identified.
(2) Diagnosed as clinical stage II or III and resectable breast cancer.
(3) Aged 18-80 years.
(4) ECOG performance status of 0 or 1.
(5) Adequate organ function within 28 days prior to registration.
(i) ANC >= 1500 cells/mm3
(ii) Hemoglobin >= 9.0 g/dL
(iii) Platelet count >= 100,000/ mm3
(iv) Serum bilirubin <= 1.5 mg/dL
(v) AST <= 100 U/L
(vi) ALT <= 100 U/L
(vii) Creatinine <= 1.2 mg/dL
(6) Ejection fraction of cardiac function is defined over 50%.
(7) No history of either non-invasive or invasive breast cancer.
(8) All of the following about prior treatment
(i) No history of anticancer drugs (including immune checkpoint inhibitors and molecular targeted drugs) for other types of cancer within past 5 years
(ii) No history of anticancer drug therapy, endocrine therapy, or surgery for the treatment of breast cancer. History of endocrine therapy for the relief of menopausal symptoms and lymph node biopsy for diagnostic purposes is acceptable.
(9) As for triple negative cohort, no autoimmune disease or history of chronic or recurrent autoimmune disease. Well controlled disease as follows are acceptable: type 1 diabetes, hyperthyroidism/hypothyroidism, and autoimmune skin diseases.
(10) Sufficient tissue was obtained from the primary tumor or axillary lymph node biopsy.
(11)Written informed consent.

Eligibility Criteria of sub-protocol
1)Histologically diagnosed as Triple-negative breast cancer.

Exclude criteria

Exclusion Criteria of master protocol
(1) Active malignancies, but the following are not excluded.
(i) Completely resected cancers: basal cell carcinoma, clinical stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, superficial bladder cancer
(ii) Gastrointestinal cancer curatively resected by ESD or EMR
(iii) Cancers that have not shown any recurrence more for 5 years or more>= 5 years prior to randomization.
(2) Infection with care.
(3) Fever up 38 degrees Celcius.
(4) Interstitial pneumonia, pulmonary fibrosis, severe emphysema diagnosed chest CT scan.
(5) Unstable angina or history of cardiac infarction within 6months.
(6) Congestive heart failure deserved class II of New York Heart Association (NYHA), uncontrolled Dilated or Hypertrophic cardiomyopathy.
(7) Continuously take steroids or immunosuppressive drugs.
(8) HBs Ag positive or HCV antibody positive
(9) All of the following: HBs Ag negative, HBV or HCV antibody positive, and HBV-DNA quantification positive
(10) Pregnant, breastfeeding or may be pregnant
(11) Severe mental disorders.

Exclusion Criteria of subprotocol
(1)Patients who meet either of followings:
(i)Patients who cannot take pills.
(ii) Malabsorption syndrome.
(iii)Diseases that significantly affect gastrointestinal function.
(iv)History of total resection of the stomach or small bowel.
(v)Ulcerative colitis.
(vi) Irritable bowel syndrome.
(vii) Intestinal obstruction.

Related Information

• Primary Sponsor: Yonemori Kan
• Source(s) of Monetary Support: Takeda Pharmaceutical Company Limited