Preoperative Treatment of Breast Cancer With Two Different Sequential Treatment Regimens

Breast Cancer Clinical Trial

Official title:

A Randomized Phase 2 Trial of Doxorubicin Plus Pemetrexed Followed by Docetaxel, Versus Doxorubicin Plus Cyclophosphamide Followed by Docetaxel, as Neoadjuvant Treatment for Early Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00149214
• Other study ID #: 7113
• Secondary ID: H3E-MC-S080
• Status: Completed
• Phase: Phase 2
• First received: September 2, 2005
• Last updated: March 15, 2012
• Start date: September 2005
• Est. completion date: March 2011

Study information

• Verified date: March 2012
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 257
• Est. completion date: March 2011
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• pemetrexed
500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4)
• cyclophosphamide
600 mg/m2, intravenous (IV), every 21 days, 4 cycles (1-4)
• doxorubicin
60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4)
• docetaxel
100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)

Locations

Country	Name	City	State
Germany	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
Germany	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
Germany	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
Germany	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
Italy	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
Italy	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
Russian Federation	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
Russian Federation	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
Spain	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.	Jaen
Spain	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
Spain	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

Germany,  Italy,  Russian Federation,  Spain, 

References & Publications (1)

Schneeweiss A, Marmé 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of Participants With a Clinical Tumor Response After the First Sequence of Chemotherapy	The number of participants with a clinical tumor response based on measurement of tumor size after the first sequence of chemotherapy, without a second confirmatory tumor measurement, per protocol.	Cycles 1-4 (21-day cycles)	No
Secondary	Number of Participants With a Clinical Tumor Response After the Second Sequence of Chemotherapy	The number of participants with a clinical tumor response based on measurement of tumor size after the second sequence of chemotherapy, without a second confirmatory tumor measurement required, per protocol.	Cycles 5-8 (21-day cycles)	No
Secondary	Number of Patients With Histologically Negative Axillary Lymph Node Status at Surgery	Histologically negative is defined as no malignant cells present in the axillary lymph nodes during surgery.	surgery after eight 21-day cycles of chemotherapy	No
Secondary	Disease-free Survival	Disease-free survival is defined as the time from date of study enrollment (randomization) to first date of progressive disease (PD) or death from any cause. PD per Response Evaluation Criteria In Solid Tumors (RECIST) criteria is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. For patients not known to have died as of the data cut-off date and who do not have progressive disease, disease-free survival was censored at the last contact date.	baseline through post surgery, follow-up for 3 years post-surgery (up to 5.2 years after randomization)	No

External Links

•   Lilly Clinical Trial Registry