Intensive vs. standard post-operative surveillance in high risk breast cancer patients (JCOG1204, INSPIRE)

Conditions

Breast Cancer

Yoichi Naito, Yukinori Ozaki, Hitoshi Tsuda, Keita Sasaki, Keisuke Kanato et al. (10 authors)

Journal of Clinical Oncology2024-05-291 citations

10.1200/jco.2024.42.16_suppl.518

Abstract OT2-01-05: A randomized controlled trial comparing post-operative intensive follow-up with standard follow-up in high-risk breast cancer patients (JCOG1204: INSPIRE)

T. Hojo, N Masuda, Taro Shibata, Tomonori Mizutani, Tadahiko Shien et al. (11 authors)

Cancer Research2019-02-15

10.1158/1538-7445.sabcs18-ot2-01-05

Abstract OT2-03-01: Multicenter study to standardize and evaluate the efficacy of radiofrequency ablation therapy for early breast cancer (RAFAELO study)

Takayoshi Sawanishi Noriyuki Kinosita, M Takahashi, Tomomi Fujisawa, Naomune Yamamoto, Hiroyoshi Doihara et al. (13 authors)

Cancer Research2019-02-15

10.1158/1538-7445.sabcs18-ot2-03-01

Intensive vs. Standard Post-Operative Surveillance in High-Risk Breast Cancer Patients (INSPIRE): Japan Clinical Oncology Group Study JCOG1204

Takashi Hojo, Norikazu Masuda, Tomonori Mizutani, Taro Shibata, Takayuki Kinoshita et al. (13 authors)

Japanese Journal of Clinical Oncology2015-08-0516 citations

10.1093/jjco/hyv110

Interventions

A: Standard follow-up Mammography and tumor marker (CEA, CA15-3) once a year, plus routine physical examination (every 3 months for the first 3 years, every 6 months for the next 2 years, and every y

tumor marker (CEA, CA15-3) every 3 months for the first 3 years, every 6 months for the next 2 year

Chest CT, abdomen CT, bone scintigraphy, brain MRI/CT twice a year for the first 3 years and every year for the next 2 years.

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Histologically proven breast cancer confirmed by biopsy or pathological examination in the resected tumor. 2. No macroscopic or microscopic residual tumor by total or partial mastectomy performed within 84 days before the registration. 3. The status of axillary lymph node confirmed by axillary resection or sentinel lymph node biopsy fulfills any of the followings: i) Having 4 or more axillary nodal metastasis in high estrogen receptor positive patients without preoperative chemotherapy ii) Having 1 or more axillary nodal metastasis in low estrogen receptor or negative patients without preoperative chemothepapy iii) Having 1 or more axillary nodal metastasis in high estrogen receptor positive patients with preoperative chemotherapy iv) Histologically proven residual invasive cancer in the breast or axilla in low estrogen receptor or negative patients with preoperative chemotherapy * High estrogen receptor positive is defined as high percentage of estrogen receptor staining (10% or more) in immunohistochemical staining, or proportion score of 3 or more in Allred score. * Low estrogen receptor positive is defined as low percentage of estrogen receptor staining (1% to less than 10%) in immunohistochemical staining, or proportion score of 2 or more in Allred score, or proportion score of 1 and intensity score of 2 to 3 in Allred score. 4. No distant metastasis found within 168 days before the registration. 5. ER status and HER2 status has already been examined. 6. No bilateral breast cancer. 7. Able to receive the examinations in each arm specified in the protocol. 8. Women aged 20 to 70 years old. 9. ECOG performance status (PS) of 0 or 1. 10. Witten informed consent.

Exclusion criteria

Exclusion criteria: 1. Simultaneous or metachronous (within 5 years) double cancers. 2. Infectious disease to be treated. 3. Psychiatric diseases. 4. Systemic and continuous steroids medication (>= 5 mg/day of prednisolone). 5. Diabetes mellitus uncontrollable 6. Uncontrollable hypertension. 7. Comorbid unstable angina pectoris or history of myocardial infarction within 6 months. 8. Interstitial pneumonitis, pulmonary fibrosis or severe pulmonary emphysema

Design outcomes

Primary

Measure	Time frame
Overall survival	—

Secondary

Measure	Time frame
Disease-free survival, Relapse-free survival, Distant metastasis-free survival, Overall survival of intrinsic subtypes, Actual number of implemented examination, Compliance of prespecified examination, Adverse events	—

Countries

Japan

Contacts

Public ContactTakashi Hojo

JCOG1204 Coordinating Office Department of Breast Surgery, National Cancer Center Hospital East

JCOG_sir@ml.jcog.jp04-7133-1111

Outcome results

None listed