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

Primary Purpose

Breast Cancer

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Apatinib

SBRT

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring oligometacosis, anti-angiogenic, apatinib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

1. 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.

Exclusion Criteria:

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;

5. 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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SBRT+apatinib group

Arm Description

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.

Outcomes

Primary Outcome Measures

Overall survival (OS)

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

Secondary Outcome Measures

Progression-free Survival (PFS)

time from randomization to documented progressive disease or death due to any cause, whichever occurs first

Adverse Events(AEs)

AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.0.

Full Information

NCT ID

NCT03457467

First Posted

March 1, 2018

Last Updated

March 1, 2018

Sponsor

Yan Li

Collaborators

Jiangsu HengRui Medicine Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03457467

Brief Title

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

Official Title

Clinical Study of Apatinib Mesylate Combined With Stereotactic Body Radiation Therapy in the Treatment of Oligometastasis of Breast Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Unknown status

Study Start Date

March 15, 2018 (Anticipated)

Primary Completion Date

March 15, 2019 (Anticipated)

Study Completion Date

March 15, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Yan Li

Collaborators

Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

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. So, through the detection of microRNA in the primary lesion of breast cancer patients with oligometastasis to screen the patients with oligomerization and potential multiple metastases; explore the existing medical treatment, based on the control of local lesions by SBRT, the use of apatinib anti-angiogenic targeted maintenance therapy, with a view to reducing the incidence of new lesions, thereby prolonging the patient's survival.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

oligometacosis, anti-angiogenic, apatinib

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SBRT+apatinib group

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Apatinib

Other Intervention Name(s)

Apatinib Mesylate Tablets

Intervention Description

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

Intervention Type

Radiation

Intervention Name(s)

SBRT

Other Intervention Name(s)

Stereotactic body radiotherapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Overall survival (OS)

Description

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

Time Frame

Approximately 3 year

Secondary Outcome Measure Information:

Title

Progression-free Survival (PFS)

Description

time from randomization to documented progressive disease or death due to any cause, whichever occurs first

Time Frame

Approximately 2 year

Title

Adverse Events(AEs)

Description

AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.0.

Time Frame

Approximately 2 years

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

breast cancer

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 1. 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. Exclusion Criteria: 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; 5. 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yan Li

Phone

18980606860

yy1240@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yan Li

Organizational Affiliation

West China Hospital

Official's Role

Study Chair

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

7931493

Citation

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.

Results Reference

background

PubMed Identifier

18719992

Citation

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.

Results Reference

background

PubMed Identifier

19997074

Citation

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. Erratum In: Nat Rev Clin Oncol. 2010 Aug;7(8):422. Dosage error in article text.

Results Reference

background

PubMed Identifier

19445579

Citation

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. Erratum In: Expert Rev Anticancer Ther. 2009 Sep;9(9):1348.

Results Reference

background

PubMed Identifier

22174856

Citation

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.

Results Reference

background

PubMed Identifier

20957176

Citation

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.

Results Reference

background

PubMed Identifier

19787069

Citation

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.

Results Reference

background

PubMed Identifier

27206146

Citation

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.

Results Reference

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

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