Clinical Application of CTDNA in Operable Breast Cancer Patients
NCT ID: NCT02797652
Last Updated: 2016-06-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
60 participants
OBSERVATIONAL
2016-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Neoadjuvant chemotherapy
ctDNA of operable breast cancer patients with neoadjuvant chemotherapy before surgery in different periods: before neo-chemotherapy, during neo-chemotherapy, on surgery day, after surgery and follow-up time.
Neoadjuvant chemotherapy before surgery
The operable breast cancer patients takes neoadjuvant chemotherapy before surgery.
Surgery
ctDNA of operable breast cancer patients with surgery followed by adjuvant chemotherapy in different periods: on surgery day, after surgery, before adjuvant chemotherapy, during adjuvant chemotherapy, and follow-up time.
Surgery followed by adjuvant chemotherapy
The operable breast cancer patients takes surgery followed by adjuvant chemotherapy.
Interventions
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Neoadjuvant chemotherapy before surgery
The operable breast cancer patients takes neoadjuvant chemotherapy before surgery.
Surgery followed by adjuvant chemotherapy
The operable breast cancer patients takes surgery followed by adjuvant chemotherapy.
Eligibility Criteria
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Inclusion Criteria
2. Age of at least 18 and at most 70 years.
3. Performance status (Karnofsky-Index) \>80%.
4. Chemotherapy is necessary before or after surgery.
5. No clinical evidence of local recurrence or distant metastases.
6. Complete staging work-up within 3 months prior to registration. All patients must have (bilateral) mammography or breast MRI, chest X-ray; other tests may be performed as clinically indicated.
7. Life expectancy of at least 2 years, disregarding the diagnosis of cancer.
8. Adequate organ function including normal red and white blood count, platelets, serum creatinine, bilirubin, and transaminases within normal range of the institution.
9. Patients must be available for and compliant to treatment and follow-up.
10. Patients registered on this trial must be treated and followed up at the participating center.
Exclusion Criteria
2. Local recurrence and/or metastasis of breast cancer.
3. No need of chemotherapy.
4. Pregnant or lactating patients. Patients of childbearing potential must have a negative pregnancy test (urine or serum) within 14 days prior to registration.
Prior or concomitant secondary malignancy (except non-melanomatous skin cancer or carcinoma in situ of the uterine cervix)
5. Any other serious medical pathology, such as congestive heart failure; unstable angina; history of myocardial infarction during the previous year; uncontrolled high risk arrhythmias
6. Other serious illness or medical condition that may interfere with the understanding and giving of informed consent and the conduct of the study.
7. Concurrent treatment with other experimental drugs or any other anti-cancer therapy.
8. Males.
18 Years
70 Years
FEMALE
No
Sponsors
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Peking Union Medical College Hospital
OTHER
Responsible Party
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Qiang SUN
Professor
Principal Investigators
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Qiang Sun, Doctor
Role: PRINCIPAL_INVESTIGATOR
Peking Union Medical College Hospital
Locations
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Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.
Crowley E, Di Nicolantonio F, Loupakis F, Bardelli A. Liquid biopsy: monitoring cancer-genetics in the blood. Nat Rev Clin Oncol. 2013 Aug;10(8):472-84. doi: 10.1038/nrclinonc.2013.110. Epub 2013 Jul 9.
Dawson SJ, Tsui DW, Murtaza M, Biggs H, Rueda OM, Chin SF, Dunning MJ, Gale D, Forshew T, Mahler-Araujo B, Rajan S, Humphray S, Becq J, Halsall D, Wallis M, Bentley D, Caldas C, Rosenfeld N. Analysis of circulating tumor DNA to monitor metastatic breast cancer. N Engl J Med. 2013 Mar 28;368(13):1199-209. doi: 10.1056/NEJMoa1213261. Epub 2013 Mar 13.
Garcia-Murillas I, Schiavon G, Weigelt B, Ng C, Hrebien S, Cutts RJ, Cheang M, Osin P, Nerurkar A, Kozarewa I, Garrido JA, Dowsett M, Reis-Filho JS, Smith IE, Turner NC. Mutation tracking in circulating tumor DNA predicts relapse in early breast cancer. Sci Transl Med. 2015 Aug 26;7(302):302ra133. doi: 10.1126/scitranslmed.aab0021.
Reinert T, Scholer LV, Thomsen R, Tobiasen H, Vang S, Nordentoft I, Lamy P, Kannerup AS, Mortensen FV, Stribolt K, Hamilton-Dutoit S, Nielsen HJ, Laurberg S, Pallisgaard N, Pedersen JS, Orntoft TF, Andersen CL. Analysis of circulating tumour DNA to monitor disease burden following colorectal cancer surgery. Gut. 2016 Apr;65(4):625-34. doi: 10.1136/gutjnl-2014-308859. Epub 2015 Feb 4.
Zill OA, Greene C, Sebisanovic D, Siew LM, Leng J, Vu M, Hendifar AE, Wang Z, Atreya CE, Kelley RK, Van Loon K, Ko AH, Tempero MA, Bivona TG, Munster PN, Talasaz A, Collisson EA. Cell-Free DNA Next-Generation Sequencing in Pancreatobiliary Carcinomas. Cancer Discov. 2015 Oct;5(10):1040-8. doi: 10.1158/2159-8290.CD-15-0274. Epub 2015 Jun 24.
Zhou Y, Xu Y, Wang C, Gong Y, Zhang Y, Yao R, Li P, Zhu X, Bai J, Guan Y, Xia X, Yang L, Yi X, Sun Q. Serial circulating tumor DNA identification associated with the efficacy and prognosis of neoadjuvant chemotherapy in breast cancer. Breast Cancer Res Treat. 2021 Aug;188(3):661-673. doi: 10.1007/s10549-021-06247-y. Epub 2021 May 18.
Other Identifiers
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PUMCH-BREAST-CTDNA
Identifier Type: -
Identifier Source: org_study_id
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