Clinical trial · Interventional
Primary Systemic Therapy in Operable/Locally Advanced Breast Cancer
Primary Systemic Therapy Using Sequential Docetaxel/Cyclophosphamide/Bevacizumab Followed by Doxorubicin in Operable/Locally Advanced Breast Cancer
NCT00203502CI-TRIAL-00022081completedPhase 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)
The main purpose of this study is to find out what effects taking the drug bevacizumab together with two chemotherapeutic agents, docetaxel and cyclophosphamide followed by doxorubicin alone before surgery will on breast cancer. Bevacizumab will be given for twelve weeks in combination with chemotherapy then it ill be held during the administration of doxorubicin. Twenty-eight to fifty-six days after undergoing surgery, all patients will receive nine three-weekly infusions of bevacizumab.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention: Dtx Cyclophosphamide Bev
- description
- Docetaxel 75m/m2 Cyclophosphamide 500 mg/m2 Bevacizumab 15 mg/kg
- interventionNames
- Drug: Bevacizumab
- Drug: Cyclophosphamide
- Drug: Docetaxel
Primary outcomes (1)
- measure
- Percentage of Participants With Pathological Complete Response.
- timeFrame
- Participants were assessed during surgery, an average of one hour
- description
- Pathological complete response was defined as the absence of residual invasive and in situ cancer on hematoxylin and eosin evaluation of the resected breast.
Secondary outcomes (4)
- measure
- Number of Participants With Clinical Complete Response in Breast and the Axillary Lymph Nodes After the Completion of Chemotherapy and Bevacizumab.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * The diagnosis of breast cancer established by biopsy. * Normal kidney function * Normal LVEF evaluated by MUGA Scan * \>18 years of age * Good performance status defined by ECOG scale of 0 or 1 * Consent * Women of childbearing potential must have a negative pregnancy test. * Use of effective means of contraception in subjects of child-bearing potential while on treatment and for at least 3 months thereafter. * Peripheral Neuropathy: must be \< grade 1 * Hematologic (minimal values) * Absolute neutrophil count \>1,500/mm3 * Hemoglobin \>8.0 g/dl * Platelet count \>100,000/mm3 * Hepatic * Total bilirubin \<ULN * AST, ALT, Alkaline Phosphatase must be within range Exclusion Criteria: * Patients with locally advanced breast cancer with skin ulcerations * Stage IV breast cancer * Inflammatory breast cancer * Allergy to any component of the treatment regimen * Women who are breast feeding * Pregnancy or refusal to use effective contraception * Inability to comply with study and/or follow-up procedures. * Current, recent, or planned participation in a experimental drug study * Blood pressure of \>150/100 mmHg. Essential hypertension well controlled with anti hypertensives is not an exclusion criterion. * unstable angina * New York Heart Association Grade II or greater congestive heart failure * history of myocardial infarction within 6 months * history of stroke within 6 months * Clinical significant peripheral vascular disease * Evidence of bleeding diathesis or coagulopathy * Presence of central nervous system or brain metastasis * major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 0 * Minor surgical procedure such as fine needle aspirations or core biopsy within 7 days prior to day 0 * Pregnant or lactating * Urine protein: creatinine ratio \>1.0 at screening * History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0 * Serious, non-healing wound, ulcer, or bone fracture
References
Publications (4)
- DERIVEDHsu PC, Kadlubar SA, Siegel ER, Rogers LJ, Todorova VK, Su LJ, Makhoul I. Genome-wide DNA methylation signatures to predict pathologic complete response from combined neoadjuvant chemotherapy with bevacizumab in breast cancer. PLoS One. 2020 Apr 16;15(4):e0230248. doi: 10.1371/journal.pone.0230248. eCollection 2020. PMID 32298288
- DERIVEDMakhoul I, Todorova VK, Siegel ER, Erickson SW, Dhakal I, Raj VR, Lee JY, Orloff MS, Griffin RJ, Henry-Tillman RS, Klimberg S, Hutchins LF, Kadlubar SA. Germline Genetic Variants in TEK, ANGPT1, ANGPT2, MMP9, FGF2 and VEGFA Are Associated with Pathologic Complete Response to Bevacizumab in Breast Cancer Patients. PLoS One. 2017 Jan 3;12(1):e0168550. doi: 10.1371/journal.pone.0168550. eCollection 2017. PMID 28045923
- DERIVEDMakhoul I, Griffin RJ, Siegel E, Lee J, Dhakal I, Raj V, Jamshidi-Parsian A, Klimberg S, Hutchins LF, Kadlubar S. High-circulating Tie2 Is Associated With Pathologic Complete Response to Chemotherapy and Antiangiogenic Therapy in Breast Cancer. Am J Clin Oncol. 2016 Jun;39(3):248-54. doi: 10.1097/COC.0000000000000046. PMID 24577164
- DERIVEDMakhoul I, Klimberg VS, Korourian S, Henry-Tillman RS, Siegel ER, Westbrook KC, Hutchins LF. Combined neoadjuvant chemotherapy with bevacizumab improves pathologic complete response in patients with hormone receptor negative operable or locally advanced breast cancer. Am J Clin Oncol. 2015 Feb;38(1):74-9. doi: 10.1097/COC.0b013e31828940c3. PMID 23563210