Clinical Application of CTDNA in Operable Breast Cancer Patients

Breast Cancer Clinical Trial

Official title:

Clinical Application of CTDNA in Operable Breast Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02797652
• Other study ID #: PUMCH-BREAST-CTDNA
• Status: Recruiting
• Phase: N/A
• First received: May 24, 2016
• Last updated: June 11, 2016
• Start date: May 2016

Study information

• Verified date: June 2016
• Source: Peking Union Medical College Hospital
• Contact: Qiang Sun, Doctor
• Phone: 86-010-69152701
• Email: sunqiangpumc[@]sina.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures.

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:

1. Known hypersensitivity reaction to the investigational compounds or incorporated substances.

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

References & Publications (6)

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;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Reinert T, Schøler 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, Ørntoft 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No