Clinical trial · Interventional
Preoperative Treatment of Breast Cancer With Two Different Sequential Treatment Regimens
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
NCT00149214CI-TRIAL-00006556completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| docetaxel | Drug | Docetaxel | ALIAS |
| doxorubicin | Drug | Doxorubicin | ALIAS |
| pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A: Pemetrexed Plus Doxorubicin, Followed by Docetaxel
- interventionNames
- Drug: pemetrexed
- Drug: doxorubicin
- Drug: docetaxel
- type
- ACTIVE_COMPARATOR
- label
- B: Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel
- interventionNames
- Drug: cyclophosphamide
- Drug: doxorubicin
- Drug: docetaxel
Primary outcomes (1)
- measure
- Number of Participants With a Pathological Complete Response
- timeFrame
- surgery after eight 21-day cycles of chemotherapy
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTSchneeweiss 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 20732932