NCT00149214

Brief Summary

An open-label randomized Phase II study in order to explore two different sequential anthracycline-based neoadjuvant treatment regimens in female patients with primary, operable breast cancer (T2-T4/N0-2/M0).

Trial Health

90
On Track

Trial Health Score

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

Enrollment
257

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline
Completed

Started Sep 2005

Typical duration for phase_2 breast-cancer

Geographic Reach
4 countries

11 active sites

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

September 1, 2005

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 2, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

May 13, 2009

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

March 21, 2012

Status Verified

March 1, 2012

Enrollment Period

2.4 years

First QC Date

September 2, 2005

Results QC Date

February 11, 2009

Last Update Submit

March 15, 2012

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With a Pathological Complete Response

    pathological assessment of tissue removed during surgery to determine if tumor tissue is still present after chemotherapy

    surgery after eight 21-day cycles of chemotherapy

Secondary Outcomes (4)

  • Number of Participants With a Clinical Tumor Response After the First Sequence of Chemotherapy

    Cycles 1-4 (21-day cycles)

  • Number of Participants With a Clinical Tumor Response After the Second Sequence of Chemotherapy

    Cycles 5-8 (21-day cycles)

  • Number of Patients With Histologically Negative Axillary Lymph Node Status at Surgery

    surgery after eight 21-day cycles of chemotherapy

  • Disease-free Survival

    baseline through post surgery, follow-up for 3 years post-surgery (up to 5.2 years after randomization)

Study Arms (2)

A: Pemetrexed Plus Doxorubicin, Followed by Docetaxel

EXPERIMENTAL
Drug: pemetrexedDrug: doxorubicinDrug: docetaxel

B: Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel

ACTIVE COMPARATOR
Drug: cyclophosphamideDrug: doxorubicinDrug: docetaxel

Interventions

pemetrexedDRUG

500 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (1-4)

Also known as: LY231514, Alimta
A: Pemetrexed Plus Doxorubicin, Followed by Docetaxel
cyclophosphamideDRUG

600 mg/m2, intravenous (IV), every 21 days, 4 cycles (1-4)

B: Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel
doxorubicinDRUG

60 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (1-4)

A: Pemetrexed Plus Doxorubicin, Followed by DocetaxelB: Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel
docetaxelDRUG

100 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (5-8)

A: Pemetrexed Plus Doxorubicin, Followed by DocetaxelB: Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed diagnosis of primary early breast cancer, tumor size greater than or equal to 2 centimeters (cm), of Stages T2-T4/N0-2.
  • Performance status 0-2 Eastern Cooperative Oncology Group (ECOG).
  • Adequate organ function (bone marrow, hepatic, renal, cardiac).

You may not qualify if:

  • Prior anthracyclines as part of prior anticancer therapy.
  • Concurrent antitumor therapy.
  • Second primary malignancy.
  • Serious concomitant systemic disorder.
  • Pre-existing sensorial or motor neuropathy
  • Grade 1.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Baden-Baden, 76532, Germany

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Berlin, 10967, Germany

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Hamburg, 20357, Germany

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Heidelberg, D-69115, Germany

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Cremona, 26100, Italy

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Rozzano, 20089, Italy

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Moscow, 129128, Russia

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Saint Petersburg, 197022, Russia

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Jaén, 23007, Spain

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Sabadell, 08208, Spain

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Valencia, 46010, Spain

Location

Related Publications (1)

  • Schneeweiss A, Marme F, Ruiz A, Manikhas AG, Bottini A, Wolf M, Sinn HP, Mansouri K, Kennedy L, Bauknecht T. A randomized phase II trial of doxorubicin plus pemetrexed followed by docetaxel versus doxorubicin plus cyclophosphamide followed by docetaxel as neoadjuvant treatment of early breast cancer. Ann Oncol. 2011 Mar;22(3):609-617. doi: 10.1093/annonc/mdq400. Epub 2010 Aug 23.

    PMID: 20732932RESULT

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

PemetrexedCyclophosphamideDoxorubicinDocetaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

GuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DicarboxylicPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicDiterpenesTerpenes

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
1-800-545-5979

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Monday-Friday 9am - 5pm Eastern time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2005

First Posted

September 8, 2005

Study Start

September 1, 2005

Primary Completion

February 1, 2008

Study Completion

March 1, 2011

Last Updated

March 21, 2012

Results First Posted

May 13, 2009

Record last verified: 2012-03

Locations

IT(2)RU(2)ES(3)DE(4)