Clinical Study of Apatinib Combined With SBRT Therapy in the Treatment of Oligometastasis of Breast Cancer
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| ClinicalTrials.gov Identifier: NCT03457467 |
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Recruitment Status : Unknown
Verified March 2018 by Yan Li, West China Hospital.
Recruitment status was: Not yet recruiting
First Posted : March 7, 2018
Last Update Posted : March 7, 2018
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Breast Cancer | Drug: Apatinib Radiation: SBRT | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 30 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Clinical Study of Apatinib Mesylate Combined With Stereotactic Body Radiation Therapy in the Treatment of Oligometastasis of Breast Cancer |
| Estimated Study Start Date : | March 15, 2018 |
| Estimated Primary Completion Date : | March 15, 2019 |
| Estimated Study Completion Date : | March 15, 2020 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Drug: Apatinib
Apatinib 500 mg is administered orally daily, until disease progression or untolerable toxicity
Other Name: Apatinib Mesylate Tablets Radiation: 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
Other Name: Stereotactic body radiotherapy |
- Overall survival (OS) [ Time Frame: Approximately 3 year ]OS is defined as the length of time from random assignment to death or to last contact.
- Progression-free Survival (PFS) [ Time Frame: Approximately 2 year ]time from randomization to documented progressive disease or death due to any cause, whichever occurs first
- Adverse Events(AEs) [ Time Frame: Approximately 2 years ]AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.0.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Gender Based Eligibility: | Yes |
| Gender Eligibility Description: | breast cancer |
| 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:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03457467
| Contact: Yan Li | 18980606860 | yy1240@163.com |
| Study Chair: | Yan Li | West China Hospital |
| Responsible Party: | Yan Li, assistant director physician, West China Hospital |
| ClinicalTrials.gov Identifier: | NCT03457467 |
| Other Study ID Numbers: |
Ahead-BC-20170323 |
| First Posted: | March 7, 2018 Key Record Dates |
| Last Update Posted: | March 7, 2018 |
| Last Verified: | March 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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oligometacosis anti-angiogenic apatinib |
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Apatinib Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |