Comparative Analysis of the Efficacies in Neoadjuvant Chemotherapy of Breast Cancer

Breast Neoplasms Clinical Trial

Official title:

Comparative Analysis of the Efficacies of AT and AC-T Regimens in Neoadjuvant Chemotherapy of Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02613026
• Other study ID #: AT2009
• Status: Completed
• Phase: Phase 3
• First received: November 3, 2015
• Last updated: November 22, 2015
• Start date: July 2009
• Est. completion date: February 2015

Study information

• Verified date: November 2015
• Source: 307 Hospital of PLA
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the short-term and long-term efficacies and the safeties of pirarubicin plus docetaxel(AT group) and pirarubicin plus cyclophosphamide followed by docetaxel(AC-T group) in neoadjuvant chemotherapy of breast cancer.

Description:

Based on the results of NSABP(National Surgical Adjuvant Breast and Bowel Project) B27 trial, anthracyclines(A) and Taxanes(T) are most commonly recommended in neoadjuvant chemotherapy of breast cancer.

Pirarubicin is one of anthracyclines and by embedding the DNA double stranded, which inhibits DNA replication and RNA synthesis, thereby impedes the rapid growth of cancer cells.

Docetaxel in one of taxanes and by strengthening the tubulin polymerization, inhibiting of microtubule depolymerization and leading to the formation of stable non functional microtubule bundles, which destroys mitosis of tumor cells.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: February 2015
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• histopathologically diagnosed with stage I-III breast cancers;

• clearly confirmed ER, PR and HER2 statuses;

• the state of axillary lymph nodes was determined through the relevant examination steps (puncture or sentinel lymph node biopsy);

• the patients were not treated with neoadjuvant therapy and surgery.

Exclusion Criteria:

• the patients whose breasts or axillary lumps had received excision biopsy;

• the patients who had severely abnormal organ functions or who could not tolerate chemotherapy,

• the patients with severe concomitant diseases;

• the patients with heart disease or left ventricular ejection fraction (LVEF) <50%.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• Pirarubicin

• Docetaxel

• Cyclophosphamide

Locations

Country	Name	City	State
China	Hunan Provincial People's Hospital	Changsha	Hunan
China	Xiangya Hospital, Central South University	Changsha	Hunan
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	Jiangsu Cancer Hospital	Nanjing	Jiangsu
China	The fourth hospital of Hebei Medical University	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
307 Hospital of PLA

Country where clinical trial is conducted

China, 

References & Publications (3)

Bear HD, Anderson S, Brown A, Smith R, Mamounas EP, Fisher B, Margolese R, Theoret H, Soran A, Wickerham DL, Wolmark N; National Surgical Adjuvant Breast and Bowel Project Protocol B-27. The effect on tumor response of adding sequential preoperative docetaxel to preoperative doxorubicin and cyclophosphamide: preliminary results from National Surgical Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol. 2003 Nov 15;21(22):4165-74. Epub 2003 Oct 14. — View Citation

Kaufmann M, Hortobagyi GN, Goldhirsch A, Scholl S, Makris A, Valagussa P, Blohmer JU, Eiermann W, Jackesz R, Jonat W, Lebeau A, Loibl S, Miller W, Seeber S, Semiglazov V, Smith R, Souchon R, Stearns V, Untch M, von Minckwitz G. Recommendations from an international expert panel on the use of neoadjuvant (primary) systemic treatment of operable breast cancer: an update. J Clin Oncol. 2006 Apr 20;24(12):1940-9. Erratum in: J Clin Oncol. 2006 Jul 1;24(19):3221. — View Citation

Mamounas EP, Brown A, Anderson S, Smith R, Julian T, Miller B, Bear HD, Caldwell CB, Walker AP, Mikkelson WM, Stauffer JS, Robidoux A, Theoret H, Soran A, Fisher B, Wickerham DL, Wolmark N. Sentinel node biopsy after neoadjuvant chemotherapy in breast cancer: results from National Surgical Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol. 2005 Apr 20;23(12):2694-702. Erratum in: J Clin Oncol. 2005 Jul 20;23(21):4808. Sovan, Atilla [corrected to Soran, Atilla]. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pathological complete response rate		one year	No
Secondary	clinical response rate		one year	No
Secondary	Percentage of changes in hormone receptors status after treatment		one year	No
Secondary	Number of relative prognostic factors which influence pCR		three years	No