Comparative Analysis of the Efficacies in Neoadjuvant Chemotherapy of Breast Cancer

NCT02613026 | Completed Phase 3

• 1 other identifier: AT2009
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Breast Neoplasms

Keywords

Breast tumor; Neoadjuvant chemotherapy; Pathological complete remission

Outcome Measures

Primary Outcomes (1)

• pathological complete response rate

  one year

Secondary Outcomes (3)

• clinical response rate

  one year

• Percentage of changes in hormone receptors status after treatment

  one year

• Number of relative prognostic factors which influence pCR

  three years

Study Arms (2)

Combined therapy group

EXPERIMENTAL

pirarubicin 50mg/m2, iv, d1; docetaxel 75mg/m2, div, d1. 21 days were a cycle of treatment, with a total of 4-8 cycles.

Drug: Pirarubicin; Drug: Docetaxel

Sequential therapy group

EXPERIMENTAL

cyclophosphamide 600mg/m2, iv, d1; Pirarubicin 60mg/m2, iv, d1, 21 days were a cycle of treatment, with a total of 4 cycles. Then followed by Docetaxel 75- 100mg/m2, div, d1, 21 days were a cycle of treatment, with a total of 4 cycles.

Drug: Pirarubicin; Drug: Docetaxel; Drug: Cyclophosphamide

Interventions

Pirarubicin DRUG

Also known as: Tetrahydropyranyl Adriamycin

Combined therapy group; Sequential therapy group

Docetaxel DRUG

Also known as: Taxotere

Combined therapy group; Sequential therapy group

Cyclophosphamide DRUG

Sequential therapy group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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%.

Sponsors & Collaborators

• 307 Hospital of PLA: lead

Study Sites (5)

The fourth hospital of Hebei Medical University

Shijiazhuang, Hebei, 050010, China

Location

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

Location

Hunan Provincial People's Hospital

Changsha, Hunan, 410005, China

Location

Xiangya Hospital, Central South University

Changsha, Hunan, 410008, China

Location

Jiangsu Cancer Hospital

Nanjing, Jiangsu, 210000, China

Location

Related Publications (3)

• 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. doi: 10.1200/JCO.2005.02.6187.

  PMID: 16622270 BACKGROUND

• 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. doi: 10.1200/JCO.2003.12.005. Epub 2003 Oct 14.

  PMID: 14559892 BACKGROUND

• 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. doi: 10.1200/JCO.2005.05.188.

  PMID: 15837984 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Pathologic Complete Response

Interventions

pirarubicin; Docetaxel; Cyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Study Officials

• Shikai Wu

  307 Hospital of PLA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician,Department of Radiotherapy

Study Record Dates

• First Submitted: November 3, 2015
• First Posted: November 24, 2015
• Study Start: July 1, 2009
• Primary Completion: March 1, 2013
• Study Completion: February 1, 2015
• Last Updated: November 24, 2015

Record last verified: 2015-11

Locations

CN (5)