Clinical trial · Interventional
Bevacizumab Plus Modified FOLFOX6 Regimen as the Salvage Treatment in Metastatic Breast Cancer (MBC) Patients
Phase II Study of Bevacizumab Plus Modified FOLFOX6 Regimen as the Salvage Treatment in Patients With Metastatic Breast Cancer
NCT01658033CI-TRIAL-00019087completedPhase 2ClinicalTrials.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 objective of this phase II study is to evaluate efficacy and safety of avastin plus modified FOLFOX6 regimen in HER-2 negative metastatic breast cancer patients. Fifty-five patients will be enrolled into this study.
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 |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Avastin + mFOLFOX6 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Avastin + mFOLFOX6
- description
- Avastin plus FOLFOX6 regimen in the management of her-2 negative breast cancer patients.
- interventionNames
- Drug: Avastin + mFOLFOX6
Primary outcomes (1)
- measure
- Progression free survival
- timeFrame
- response evaluation every two cycles
Secondary outcomes (1)
- measure
- Number of adverse events
- timeFrame
- 8 weeks
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. age\>=18years 2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) \<=2 and a life expectancy \>= 12 weeks; 3. histological-proven, HER-2 negative measurable stage IV disease; 4. exposure to anthracyclines, taxanes either in the neoadjuvant/adjuvant or in the metastatic setting and had documented disease progression after the firstline or secondline treatment 5. Patients previously treated with radiotherapy were eligible for the study, provided that measurable disease existed outside the radiation field. 6. At least 3 weeks from the prior chemotherapy or radiotherapy. At least 2 weeks from the prior endocrine therapy. Exclusion Criteria: 1. Patients with active infection or other serious underlying medical conditions 2. Patients had prior treatment with 5-FU infusion and/or oxaliplatin therapy 3. Inadequate bone marrow, liver, renal, medullary, and cardiac functions 4. Evidence of spinal cord compression or brain metastasis 5. History of another malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix or a contralateral breast cancer 6. Pregnant or lactating women 7. Serious uncontrolled intercurrent infection 8. History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding 9. Serious non-bleeding wound, peptic ulcer or bone fracture 10. Prior dihypopyrimidine dehydrogenase deficiency 11. Hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanlised antibodies
References
Publications (5)
- BACKGROUNDParkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin. 2005 Mar-Apr;55(2):74-108. doi: 10.3322/canjclin.55.2.74. PMID 15761078
- BACKGROUNDKamby C, Vejborg I, Kristensen B, Olsen LO, Mouridsen HT. Metastatic pattern in recurrent breast cancer. Special reference to intrathoracic recurrences. Cancer. 1988 Nov 15;62(10):2226-33. doi: 10.1002/1097-0142(19881115)62:103.0.co;2-d. PMID 3179937
- BACKGROUNDJemal A, Siegel R, Ward E, Murray T, Xu J, Thun MJ. Cancer statistics, 2007. CA Cancer J Clin. 2007 Jan-Feb;57(1):43-66. doi: 10.3322/canjclin.57.1.43. PMID 17237035
- BACKGROUNDPectasides D, Pectasides M, Farmakis D, Bountouroglou N, Nikolaou M, Koumpou M, Mylonakis N, Kosmas C. Oxaliplatin plus high-dose leucovorin and 5-fluorouracil in pretreated advanced breast cancer: a phase II study. Ann Oncol. 2003 Apr;14(4):537-42. doi: 10.1093/annonc/mdg172. PMID 12649097
- DERIVEDLi T, Wang B, Wang Z, Ragaz J, Zhang J, Sun S, Cao J, Lv F, Wang L, Zhang S, Ni C, Wu Z, Xie J, Hu X. Bevacizumab in Combination with Modified FOLFOX6 in Heavily Pretreated Patients with HER2/Neu-Negative Metastatic Breast Cancer: A Phase II Clinical Trial. PLoS One. 2015 Jul 17;10(7):e0133133. doi: 10.1371/journal.pone.0133133. eCollection 2015. PMID 26186012