JCOG1017: A randomized controlled trial comparing primary tumor resection plus systemic therapy with systemic therapy alone in metastatic breast cancer

JRCT ID: jRCTs031180151

Registered date:25/02/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Metastatic breast cancer
• Date of first enrollment: 22/06/2011
• Target sample size: 600
• Study type: Interventional

Intervention(s)

A: Systemic therapy alone
B: Primary tumor resection plus systemic therapy

Outcome(s)

• Primary Outcome: Overall survival
• Secondary Outcome: Proportion of patients without progression in metastatic sites, yearly local recurrence-free survival, incidence of local ulcer/local bleeding, yearly primary tumor resection-free survival, adverse events of chemotherapy, operative morbidity, serious adverse events.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Female

Include criteria

First registration
1. Histologically proven breast cancer confirmed by biopsy from the tumor.
2. Presense/absence of overexpression of estrogen receptor (ER) and HER2 was examined by IHC or FISH or DISH analyses.
3. Neither bilateral breast cancer nor invasion to contralateral breast.
4. At least one measurable lesion other than the breast tumor and ipsilateral axillary lymph nodes was detected by CT or MRI before primary registration.
5. No brain metastasis.
6. Women aged 20 to 80 years old.
7. ECOG performance status (PS) of 0 or 1. PS of 2 caused by the symptom from bone metastasis is also eligible.
8. No prior surgery, chemotherapy or radiotherapy for any other malignancies within 5 years.
9. No history of invasive breast cancer. Non-invasive breast cancer resected completely by partial mastectomy is eligible.
10. Neither prior chemotherapy for breast cancer nor prior radiotherapy for ipsilateral breast (radiotherapy for bone metastasis within 30Gy and 10 times before registration is allowed).
11. Sufficient organ functions.
12. Witten informed consent.

Second registration (after primary chemotherapy)
1. Primary chemotherapy was performed after the first registration and protocol treatment is not discontinued.
2. Objective response of primary chemotherapy was neither PD nor NE.
3. Within 28 days from the date of response evaluation.
4. Sufficient organ functions.
5. Complete resection is expected to be possible by total or patial mastectomy without resection of adjacent organs and/or wide skin transplant.
6. No active bleeding from breast tumor which necessitates blood transfusion within 28 days before second regstration.

Exclude criteria

First registration (no exclusion criteria at second registration)
1. Simultaneous or metachronous (within 5 years) double cancers.
2. Infectius disease to be treated.
3. Body temperature of 38C or higher.
4. Women during pregnancy or breast-feeding.
5. Psychiatric diseases.
6. Systemic and continuous steroids medication.
7. Comorbid unstable angina pectoris or history of myocardial infarction within 6 months.
8. Uncotrollable hypertension.
9. Diabetes mellitus uncontrollable or treated by continuous insulin administration .

Related Information

• Primary Sponsor: IWATA Hiroji
• Source(s) of Monetary Support: National Cancer Center Japan,Ministry of Health, Labour and Welfare,Japan Agency for Medical Research and Development
• Secondary ID(s): UMIN000005586