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Status unknownNCT03457467Updated Mar 7, 2018

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

A Phase 2 interventional study of Apatinib and SBRT in Breast Cancer, sponsored by Yan Li. Status unknown. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-07.

Sponsored by Yan Li · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Breast Cancer

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Keywords

  • oligometacosis
  • anti-angiogenic
  • apatinib
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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

Exclusion Criteria:

  1. After the above image examination of the whole body metastasis lesions ≥ 6;
  2. Have received one or more palliative chemotherapy regulators failed;
  3. 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;
  1. 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
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    SBRT+apatinib group

    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

  • DrugApatinib

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

    Also known as: Apatinib Mesylate Tablets

  • RadiationSBRT

    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

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What researchers measure

Primary outcomes

  1. Overall survival (OS)

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

    Time frame: Approximately 3 year

Secondary outcomes

  1. Progression-free Survival (PFS)

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

    Time frame: Approximately 2 year

  2. Adverse Events(AEs)

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

    Time frame: Approximately 2 years

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 7931493 ↗
  • 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. PubMed 18719992 ↗
  • 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. PubMed 19997074 ↗
  • 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. PubMed 19445579 ↗
  • 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. PubMed 22174856 ↗
  • 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. PubMed 20957176 ↗
  • 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. PubMed 19787069 ↗
  • 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. PubMed 27206146 ↗

Individual participant data

Plan to share: Undecided

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Registry details

Key details

Study ID
NCT03457467
Lead sponsor
Yan Li
Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Responsible party
Yan Li (assistant director physician, West China Hospital) — Sponsor-investigator
First posted
Mar 7, 2018
Start date
Mar 15, 2018 (estimated)
Primary completion
Mar 15, 2019 (estimated)
Completion
Mar 15, 2020 (estimated)
Last update
Mar 7, 2018

Study contacts

Yan Li
Contact
yy1240@163.com
18980606860
Yan Li
study chair · West China Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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