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

This study has been completed.

Sponsor:

Collaborators:

Pharmacia and Upjohn

Eli Lilly and Company

Aventis Pharmaceuticals

Information provided by (Responsible Party):

SCRI Development Innovations, LLC

ClinicalTrials.gov Identifier:

NCT00193050

First received: September 12, 2005

Last updated: August 22, 2012

Last verified: August 2012

History of Changes

Results First Received: August 22, 2012

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Breast Cancer
Interventions:	Drug: Gemcitabine Drug: Epirubicin Drug: Docetaxel

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Intervention	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.

Description

Intervention

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.

Participant Flow for 3 periods

Period 1: Neoadjuvant Treatment

	Intervention
STARTED	110
COMPLETED	101
NOT COMPLETED	9
Lack of Efficacy	2
Intercurrent Illness	3
Physician Decision	2
Adverse Event	2

Period 2: Surgery

	Intervention
STARTED	103 ^[1]
COMPLETED	103
NOT COMPLETED	0

[1]	2 patients had surgery after 2 cycles of neoadjuvant treatment

Period 3: Adjuvant

	Intervention
STARTED	87 ^[1]
COMPLETED	77
NOT COMPLETED	10
Physician Decision	5
Intercurrent Hospitalization	3
Lack of Efficacy	2

[1]	16 patients never initiated postoperative adjuvant therapy

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Intervention	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.

Description

Intervention

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.

Baseline Measures

	Intervention
Number of Participants [units: participants]	110
Age [units: years] Median ( Full Range )	51 ( 27 to 75 )
Gender [units: participants]
Female	110
Male	0
Region of Enrollment [units: participants]
United States	110

Outcome Measures

1. Primary:

Pathologic Complete Response (pCR) [ Time Frame: 18 Months ]

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2. Secondary:

Time to Treatment Failure (TTF) [ Time Frame: 69 months ]

Results not yet reported. Anticipated Reporting Date: No text entered. Safety Issue: No

3. Secondary:

Overall Survival (OS) [ Time Frame: 48 months ]

Results not yet reported. Anticipated Reporting Date: No text entered. Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The sponsor can review/embargo results communications prior to public release for a period that is >60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.

Results Point of Contact:

Name/Title: John D. Hainsworth, MD
Organization: Sarah Cannon Research Institute
phone: 877-691-7274
e-mail: ASKSarah@scresearch.net

Publications of Results:

Yardley DA, Peacock NW, Dickson NR, White MB, Vázquez 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.

Responsible Party:	SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:	NCT00193050 History of Changes
Other Study ID Numbers:	SCRI BRE 51
Study First Received:	September 12, 2005
Results First Received:	August 22, 2012
Last Updated:	August 22, 2012
Health Authority:	United States: Institutional Review Board

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