NCT00193063

Brief Summary

Due to its remarkable activity as salvage treatment in women with metastatic breast cancer as well as the additive activity observed for gemcitabine administered in combination with trastuzumab, the clinical activity of the combination of gemcitabine administered with trastuzumab represents an exciting and ideal combination to further evaluate in Her 2 over-expressing metastatic breast cancer patients.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for phase_2 breast-cancer

Timeline
Completed

Started Jul 2001

Longer than P75 for phase_2 breast-cancer

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2001

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
4.6 years until next milestone

Results Posted

Study results publicly available

March 12, 2014

Completed
Last Updated

March 12, 2014

Status Verified

February 1, 2014

Enrollment Period

7.8 years

First QC Date

September 12, 2005

Results QC Date

August 16, 2013

Last Update Submit

February 10, 2014

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall Response Rate (ORR)

    The Percentage of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

    18 Months

Secondary Outcomes (2)

  • Progression Free Survival (PFS)

    21 Months

  • Overall Survival (OS)

    24 months

Study Arms (1)

Intervention

EXPERIMENTAL

All patients entering this trial received treatment with a combination of gemcitabine and trastuzumab. Gemcitabine 1000 mg/m2 was administered intravenously on days 1, 8,and 15 of a 28-day cycle. Trastuzumab was administered as a 4 mg/kg intravenous loading dose on day 1 and subsequently at a dose of 2 mg/kg on a weekly basis.

Drug: TrastuzumabDrug: Gemcitabine

Interventions

TrastuzumabDRUG

Trastuzumab

Also known as: Herceptin
Intervention
GemcitabineDRUG

Gemcitabine

Also known as: Gemzar
Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To be included in this study, you must meet the following criteria:
  • Her-2 positive metastatic breast cancer confirmed by biopsy
  • Measurable disease
  • Able to perform activities of daily living without considerable
  • No previous chemotherapy with gemcitabine
  • No more than one prior chemotherapy regimen for metastatic breast cancer
  • Adequate bone marrow, liver and renal function
  • Normal heart function
  • Give written informed consent prior to entering this study.

You may not qualify if:

  • You cannot participate in this study if any of the following apply to you:
  • Received previous treatment with gemcitabine
  • History of brain metastases
  • Serious underlying medical conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Yardley DA, Burris HA 3rd, Hanson S, Greco FA, Spigel DR, Barton J, Hainsworth JD. Weekly gemcitabine and trastuzumab in the treatment of patients with HER2-overexpressing metastatic breast cancer. Clin Breast Cancer. 2009 Aug;9(3):178-83. doi: 10.3816/CBC.2009.n.029.

    PMID: 19661042RESULT

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

TrastuzumabGemcitabine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

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

July 1, 2001

Primary Completion

May 1, 2009

Study Completion

August 1, 2009

Last Updated

March 12, 2014

Results First Posted

March 12, 2014

Record last verified: 2014-02