Clinical Study of Apatinib Combined With SBRT Therapy in the Treatment of Oligometastasis of Breast Cancer

NCT03457467 | Unknown Phase 2

• 1 other identifier: Ahead-BC-20170323
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The treatment of the patients with metastatic breast cancer remains a major problem. However, there is an intermediate state between the primary tumor and distant metastases called oligometastasis. Current research indicates that good local control of oligometastasis can be obtained with Stereotactic body radiotherapy (SBRT) Can not prolong the long-term survival of patients. Researchers believe that after SBRT treatment of patients with oligometacosis in breast cancer, it is necessary to explore whether the anti-angiogenic therapy targeted drug apatinib can reduce the occurrence of new lesions and prolong the survival of patients.

Conditions

Breast Cancer

Keywords

oligometacosis; anti-angiogenic; apatinib

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  OS is defined as the length of time from random assignment to death or to last contact.

  Approximately 3 year

Secondary Outcomes (2)

• Progression-free Survival (PFS)

  Approximately 2 year

• Adverse Events(AEs)

  Approximately 2 years

Study Arms (1)

SBRT+apatinib group

EXPERIMENTAL

Apatinib mesylate tablets: 500mg / day, 28 days / cycle, follow-up to the progress of the disease, toxicity intolerable or patients require withdrawal; SBRT: according to the different treatment sites given the corresponding dose: 1200cGy × 4 times or 800cGy × 7 times, or according to the specific situation dose adjustment.

Drug: Apatinib; Radiation: SBRT

Interventions

Apatinib DRUG

Apatinib 500 mg is administered orally daily, until disease progression or untolerable toxicity

Also known as: Apatinib Mesylate Tablets

SBRT+apatinib group

SBRT RADIATION

according to the different treatment sites given the corresponding dose: 1200cGy × 4 times or 800cGy × 7 times, or according to the specific situation dose adjustment

Also known as: Stereotactic body radiotherapy

SBRT+apatinib group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: breast cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age: ≥ 18 years old women; 2. Histologically confirmed breast cancer; 3 weeks before enrollment ECOG PS score: 0-2 points; 4. systemic metastasis lesions ≤ 5, Stereotactic body radiotherapy before receiving medical treatment to achieve partial relief or stable disease; 5. Appropriate hematological parameters and liver and kidney function: absolute neutrophil ≧ 1.5 × 109 / L; platelet count ≧ 75 × 109 / L; serum total bilirubin ≦ 1.5 × upper limit of normal; AST and ALT ≦ 2.5 × upper limit of normal (if liver dysfunction) 6. Subject voluntarily joined the study and signed the informed consent form.

You may not qualify if:

• After the above image examination of the whole body metastasis lesions ≥ 6;
• Have received one or more palliative chemotherapy regulators failed;
• Patients with a high risk of bleeding: active gastric digestive ulcer in the stomach with fecal occult blood (++); those with a history of melena and / or vomiting within 3 months; persons with abnormal coagulation and bleeding tendency; 3-4 grade hypertension patients;
• \. Renal insufficiency 3 and above patients; 6. Hand-foot syndrome ≥ 3 or more patients; 7. There are uncontrolled concomitant diseases in the first 6 months of the study, including unstable angina pectoris, acute myocardial infarction, cerebrovascular accident and so on; 8. Pregnant or breastfeeding patients, or who have fertility without taking contraceptive measures; 9. A history of malignancy, but disease-free survival of more than 5 years; 10. Concurrent with other anti-cancer therapies or other interventional clinical trials; 11. Patients unable to follow the study due to psychological, family-living social reasons

Sponsors & Collaborators

• Yan Li: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Related Publications (8)

• Hellman S. Karnofsky Memorial Lecture. Natural history of small breast cancers. J Clin Oncol. 1994 Oct;12(10):2229-34. doi: 10.1200/JCO.1994.12.10.2229. No abstract available.

  PMID: 7931493 BACKGROUND

• Milano MT, Zhang H, Metcalfe SK, Muhs AG, Okunieff P. Oligometastatic breast cancer treated with curative-intent stereotactic body radiation therapy. Breast Cancer Res Treat. 2009 Jun;115(3):601-8. doi: 10.1007/s10549-008-0157-4. Epub 2008 Aug 22.

  PMID: 18719992 BACKGROUND

• Lo SS, Fakiris AJ, Chang EL, Mayr NA, Wang JZ, Papiez L, Teh BS, McGarry RC, Cardenes HR, Timmerman RD. Stereotactic body radiation therapy: a novel treatment modality. Nat Rev Clin Oncol. 2010 Jan;7(1):44-54. doi: 10.1038/nrclinonc.2009.188. Epub 2009 Dec 8.

  PMID: 19997074 BACKGROUND

• Lo SS, Fakiris AJ, Teh BS, Cardenes HR, Henderson MA, Forquer JA, Papiez L, McGarry RC, Wang JZ, Li K, Mayr NA, Timmerman RD. Stereotactic body radiation therapy for oligometastases. Expert Rev Anticancer Ther. 2009 May;9(5):621-35. doi: 10.1586/era.09.15.

  PMID: 19445579 BACKGROUND

• Lussier YA, Xing HR, Salama JK, Khodarev NN, Huang Y, Zhang Q, Khan SA, Yang X, Hasselle MD, Darga TE, Malik R, Fan H, Perakis S, Filippo M, Corbin K, Lee Y, Posner MC, Chmura SJ, Hellman S, Weichselbaum RR. MicroRNA expression characterizes oligometastasis(es). PLoS One. 2011;6(12):e28650. doi: 10.1371/journal.pone.0028650. Epub 2011 Dec 13.

  PMID: 22174856 BACKGROUND

• Elson-Schwab I, Lorentzen A, Marshall CJ. MicroRNA-200 family members differentially regulate morphological plasticity and mode of melanoma cell invasion. PLoS One. 2010 Oct 4;5(10):e13176. doi: 10.1371/journal.pone.0013176.

  PMID: 20957176 BACKGROUND

• Dykxhoorn DM, Wu Y, Xie H, Yu F, Lal A, Petrocca F, Martinvalet D, Song E, Lim B, Lieberman J. miR-200 enhances mouse breast cancer cell colonization to form distant metastases. PLoS One. 2009 Sep 29;4(9):e7181. doi: 10.1371/journal.pone.0007181.

  PMID: 19787069 BACKGROUND

• Wong AC, Watson SP, Pitroda SP, Son CH, Das LC, Stack ME, Uppal A, Oshima G, Khodarev NN, Salama JK, Weichselbaum RR, Chmura SJ. Clinical and molecular markers of long-term survival after oligometastasis-directed stereotactic body radiotherapy (SBRT). Cancer. 2016 Jul 15;122(14):2242-50. doi: 10.1002/cncr.30058. Epub 2016 May 20.

  PMID: 27206146 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

apatinib; Radiosurgery

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Yan Li

  West China Hospital

  STUDY CHAIR

Central Study Contacts

Yan Li

CONTACT

18980606860; yy1240@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assistant director physician

Study Record Dates

• First Submitted: March 1, 2018
• First Posted: March 7, 2018
• Study Start: March 15, 2018
• Primary Completion: March 15, 2019
• Study Completion: March 15, 2020
• Last Updated: March 7, 2018

Record last verified: 2018-03