Clinical trial · Interventional
Bevacizumab With or Without Cyclophosphamide and Methotrexate: A Pilot Study in Women With Operable Breast Cancer
Anti-Angiogenesis Treatment After Preoperative Chemotherapy: A Pilot Study in Women With Operable Breast Cancer
- 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 purpose of this research study is to study the effects (good and bad) of bevacizumab alone, bevacizumab with low-dose continuous chemotherapy (called metronomic chemotherapy), or bevacizumab with capecitabine, on you and your cancer. The goals of the study will be to: * Examine the safety of these drugs * See how easy or difficult it is to be treated with them * Monitor for any signs of recurrent cancer * Look at blood markers that might indicate how the treatment is working
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 |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Capecitabine | Drug | Capecitabine | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Methotrexate | Drug | Methotrexate | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Group A
- description
- Bevacizumab Alone
- interventionNames
- Drug: Bevacizumab
- type
- EXPERIMENTAL
- label
- Group B
- description
- Bevacizumab with cyclophosphamide and methotrexate
- interventionNames
- Drug: Bevacizumab
- Drug: Cyclophosphamide
- Drug: Methotrexate
- type
- EXPERIMENTAL
- label
- Group C
- description
- capecitabine, 14 days on/7 days off scheduling, and bevacizumab
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed invasive breast cancer, preoperative stages II-III per AJCC 6th edition, based on baseline evaluation by clinical examination and/or breast imaging * Patients must have completed preoperative (neoadjuvant) chemotherapy with a standard chemotherapy regimen. No more chemotherapy should be planned. * Patients must have completed definitive resection of primary tumor with adequate excision of gross disease. * For patients receiving adjuvant radiation therapy, treatment must be completed prior to initiation of protocol therapy. * Patients must have the presence of significant residual invasive disease on pathologic review following their preoperative chemotherapy. * LVEF \> institutional limits of normal after preoperative chemotherapy, as assessed by ECHO or nuclear medicine gated study, within 30 days prior to initiating protocol-based treatment. * ECOG performance status 0-1 Exclusion Criteria: * Inadequate organ function, as measured by laboratory assessment after preoperative chemotherapy and within 14 days of beginning protocol-based treatment * Patients with metastatic disease are ineligible. * Known HIV infection * Patients may not be pregnant, expect to become pregnant, plan to conceive a child while on study, or breastfeeding * Uncontrolled intercurrent illness * Non-healing wounds or major surgical procedures (such as breast surgery) other than that for venous access device or diagnostic study are not permitted within 28 day prior to enrollment * History of abdominal fistula, GI perforation, intra-abdominal abscess, or serious, non-healing wound, ulcer, or bone fracture within 6 months prior to initiating bevacizumab * Patients with any history of arterial thromboembolic events, including transient ischemic attack (TIA), cerebrovascular event (CVA), unstable angina, or myocardial infarction (MI) within the past 6 months. Patients with clinically significant peripheral arterial disease should also be excluded * History of bleeding diathesis or coagulopathy * History of grade 3 or 4 allergic reactions to compounds of similar chemical or biologic composition to cyclophosphamide (such as other alkylating agents) or methotrexate (such as other antimetabolites) * Prior history of malignancy treated without curative intent, excluding nonmelanomatous skin cancer * Patients with large or rapidly accumulating pleural or abdominal effusions * Current use of anticoagulants is allowed as long as patients have been on a stable dose for more than two weeks with stable INR * Chronic therapy with full dose aspirin (\< 325 mg/day) or standard non-steroidal anti-inflammatory agents is allowed * Patients may not receive other investigational agents while on study
References
Publications (1)
- DERIVEDTrapani D, Jin Q, Miller KD, Rugo HS, Reeder-Hayes KE, Traina T, Abdou Y, Falkson C, Abramson V, Ligibel J, Chen W, Come S, Nohria A, Ryabin N, Tayob N, Tolaney SM, Burstein HJ, Mayer EL. Optimizing Postneoadjuvant Treatment of Residual Breast Cancer With Adjuvant Bevacizumab Alone, With Metronomic or Standard-Dose Chemotherapy: A Combined Analysis of DFCI 05-055 and DFCI 09-134/TBCRC 012/ABCDE Clinical Trials. Clin Breast Cancer. 2025 Jun;25(4):e419-e430.e5. doi: 10.1016/j.clbc.2024.12.018. Epub 2024 Dec 31. PMID 39890560