Weekly Gemcitabine, Epirubicin, and Docetaxel in Locally Advanced or Inflammatory Breast Cancer

NCT00193050 | Completed Phase 2 Results

• 1 other identifier: SCRI BRE 51
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief Summary

Treatment strategies that include induction chemotherapy have several potential advantages: early initiation of systemic chemotherapy, in vivo assessment of response, and down-staging of both the primary tumor and regional lymphatic metastases, making breast conservation an option for many. The aim of the present study is to determine the efficacy and toxicity of induction combination chemotherapy with the triplet, gemcitabine, epirubicin, and docetaxel, in patients with locally advanced or inflammatory breast cancer. Clearly, it is in the upfront treatment as well as in the adjuvant treatment of breast cancer, that effective new agents and combination of agents are likely to have the greatest potential impact.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Pathologic Complete Response (pCR)

  For the purpose of this study, a Pathologic complete response (pCR) was defined as no evidence of residual invasive tumor in the breast (pT0). Residual ductal or lobular carcinoma in situ was not considered in pCR assessments. Percentage of participants who experienced pCR is reported.

  18 Months

Secondary Outcomes (2)

• Time to Treatment Failure (TTF)

  69 months

• Overall Survival (OS)

  48 months

Study Arms (1)

Intervention

EXPERIMENTAL

In the neoadjuvant setting, patients were administered gemcitabine (800 mg/m2 IV days 1 and 8), epirubicin (75 mg/m2 IV day 1), and docetaxel (30 mg/m2 IV days 1 and 8)repeated every 21 days for 4 cycles Patients then had either mastectomy or breast conservation surgery and pathologic treatment responses were assessed. After surgery, 4 cycles of adjuvant gemcitabine (1000 mg/m2 IV days 1 and 8) and docetaxel (35 mg/m2 IV days 1 and 8) were administered at 21 day intervals. After completion of chemotherapy, local regional radiation therapy and/or anti-estrogen therapy was administered per standard guidelines.

Drug: Gemcitabine; Drug: Epirubicin; Drug: Docetaxel

Interventions

Gemcitabine DRUG

Gemcitabine

Also known as: Gemzar

Intervention

Epirubicin DRUG

Epirubicin

Also known as: Ellence

Intervention

Docetaxel DRUG

Docetaxel

Also known as: Taxotere

Intervention

Eligibility Criteria

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

You may qualify if:

• To be included in this study, you must meet the following criteria:
• Adenocarcinoma of the breast confirmed by biopsy
• Female Patients \>18 years of age
• Normal cardiac function
• Ability to perform activities of daily living with minimal assistance
• Chemotherapy naïve or have received prior chemotherapy \> 5 years ago
• Adequate bone marrow, liver and kidney function
• Be informed of the investigational nature of this study
• Sign an informed consent form
• Sentinel lymph node and/or axillary dissection prior to enrollment

You may not qualify if:

• You cannot participate in this study if any of the following apply to you:
• Life expectancy of \< than 6 months
• History of significant heart disease
• Prior chemotherapy or hormonal therapy
• Concurrent Trastuzumab therapy
• History of significant psychiatric disorders
• History of active uncontrolled infection

Sponsors & Collaborators

• SCRI Development Innovations, LLC: lead
• Pharmacia and Upjohn: collaborator
• Eli Lilly and Company: collaborator
• Aventis Pharmaceuticals: collaborator

Related Publications (1)

• Yardley DA, Peacock NW, Dickson NR, White MB, Vazquez ER, Foust JT, Grapski R, Hendricks LK, Scott WL, Hainsworth JD. A phase II trial of neoadjuvant gemcitabine, epirubicin, and docetaxel as primary treatment of patients with locally advanced or inflammatory breast cancer. Clin Breast Cancer. 2010 Jun;10(3):217-23. doi: 10.3816/CBC.2010.n.029.

  PMID: 20497920 RESULT

Related Links

• Published article in Clinical Breast Cancer

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Gemcitabine; Epirubicin; Docetaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes

Results Point of Contact

• Title: John D. Hainsworth, MD
• Organization: Sarah Cannon Research Institute

ASKSarah@scresearch.net

877-691-7274

Study Officials

• Denise A. Yardley, MD

  SCRI Development Innovations, LLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 19, 2005
• Study Start: November 1, 2001
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2009
• Last Updated: October 26, 2021
• Results First Posted: September 21, 2012

Record last verified: 2021-10