Clinical Application of CTDNA in Operable Breast Cancer Patients
1 other identifier
observational
60
1 country
1
Brief Summary
Our study aims to evaluate the possibility of clinical application of CTDNA detection in samples or peripheral blood of breast cancer patients, so as to act as the new techniques or indicators of early diagnosis, therapy efficiency, or postoperative surveillance of breast cancer.
Trial Health
Trial Health Score
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participants targeted
Target at P25-P50 for all trials
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 24, 2016
CompletedFirst Posted
Study publicly available on registry
June 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2018
CompletedJune 14, 2016
June 1, 2016
1.9 years
May 24, 2016
June 11, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The number of ctDNA copies per milliliter in patients' peripheral blood
The number of ctDNA copies per milliliter in patients' peripheral blood of neoadjuvant chemotherapy group and surgery group in different periods
2 years
Study Arms (2)
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.
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.
Interventions
The operable breast cancer patients takes neoadjuvant chemotherapy before surgery.
The operable breast cancer patients takes surgery followed by adjuvant chemotherapy.
Eligibility Criteria
Operable breast cancer patients who need chemotherapy before or after surgery.
You may qualify if:
- Written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures.
- Age of at least 18 and at most 70 years.
- Performance status (Karnofsky-Index) \>80%.
- Chemotherapy is necessary before or after surgery.
- No clinical evidence of local recurrence or distant metastases.
- 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.
- Life expectancy of at least 2 years, disregarding the diagnosis of cancer.
- Adequate organ function including normal red and white blood count, platelets, serum creatinine, bilirubin, and transaminases within normal range of the institution.
- Patients must be available for and compliant to treatment and follow-up.
- Patients registered on this trial must be treated and followed up at the participating center.
You may not qualify if:
- Known hypersensitivity reaction to the investigational compounds or incorporated substances.
- Local recurrence and/or metastasis of breast cancer.
- No need of chemotherapy.
- 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)
- Any other serious medical pathology, such as congestive heart failure; unstable angina; history of myocardial infarction during the previous year; uncontrolled high risk arrhythmias
- Other serious illness or medical condition that may interfere with the understanding and giving of informed consent and the conduct of the study.
- Concurrent treatment with other experimental drugs or any other anti-cancer therapy.
- Males.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Related Publications (7)
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.
PMID: 26808342BACKGROUNDCrowley 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.
PMID: 23836314BACKGROUNDDawson 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.
PMID: 23484797BACKGROUNDGarcia-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.
PMID: 26311728BACKGROUNDReinert 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.
PMID: 25654990BACKGROUNDZill 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.
PMID: 26109333BACKGROUNDZhou 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.
PMID: 34003409DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Qiang Sun, Doctor
Peking Union Medical College Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 24, 2016
First Posted
June 13, 2016
Study Start
May 1, 2016
Primary Completion
April 1, 2018
Last Updated
June 14, 2016
Record last verified: 2016-06