Breast CancerNCT00121134
Bevacizumab With or Without Cyclophosphamide and Methotrexate: A Pilot Study in Women With Operable Breast Cancer
A study testing Bevacizumab, Cyclophosphamide and Methotrexate in people with Breast Cancer, run by Harold J. Burstein, MD, PhD at 5 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Bevacizumab, Cyclophosphamide and Methotrexate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 5 sitesUnited States
- Study dates
- Jun 2005to May 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
University of North Carolina
Durham, North Carolina, 27701
Indiana University Cancer Center
Indianapolis, Indiana, 46202
University of California, San Francisco
San Francisco, California, 94122
About this study
Official title: Anti-Angiogenesis Treatment After Preoperative Chemotherapy: A Pilot Study in Women With Operable Breast Cancer
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
Read the detailed description
This study is broken into 4 groups (A, B, C, and D). Enrollment closed to all groups in May 2008.
The first forty subjects (Group A) in this study were treated with Bevacizumab only, which is given through a vein over 1-2 hours every 3 weeks, for a total of approximately 12 months (17 cycles). Each cycle consists of 3 weeks.
The next forty subjects (Group B) were treated with Bevacizumab and metronomic CM chemotherapy. These subjects took cyclophosphamide (1 pill by mouth every day), methotrexate, (1 pill taken by mouth twice a day for the first two days of each week) and Bevacizumab (once every 3 weeks). The treatments with cyclophosphamide, methotrexate and Bevacizumab will continue for approximately 6 months (8 cycles). Then for the next 6 months, they received Bevacizumab treatments only. The total time on this study will be about 12 months (17 cycles).
The next forty subjects (Group C) were treated with Bevacizumab and Capecitabine chemotherapy. These subjects took Capecitabine pills twice a day for 14 days, then one week of rest, to complete a 21-day cycle. There will be a total of 6 cycles of Capecitabine, meaning 18 weeks of treatment with both Capecitabine and Bevacizumab. Then received Bevacizumab treatments only (11 cycles) to complete 12 months of therapy. Total duration of your treatment will be about 12 months or 17 cycles of therapy.
The last forty subjects (Group D) are being treated with Bevacizumab and Capecitabine chemotherapy on a different schedule. These subjects will take Capecitabine pills twice a day for 7 days, then one week of rest and repeat this for a total of 24 weeks (6 cycles). Each cycle will last for 4 weeks (28 days). There will be a total of 6 cycles of Capecitabine, meaning 24 weeks of treatment with both Capecitabine and Bevacizumab. Bevacizumab will be given every two weeks for a total of 24 weeks (6 cycles). Then they will receive Bevacizumab treatments only, every 3 weeks for additional 27 weeks (9 cycles) to complete 12 months of therapy. For the last 9 cycles of Bevacizumab therapy each cycle will consist of 3 weeks. Total duration of treatment will be about 12 months or 15 cycles of therapy.
- Conditions
- Breast Cancer
- Being tested
- Bevacizumab, Cyclophosphamide, Methotrexate, Capecitabine
- Keywords
- Bevacizumab, Metronomic Chemotherapy, Breast Cancer Stages II-III, Invasive breast cancer stages II-III
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Avastin
Group A: Once every 3 weeks for 12 months Group B: Once every 3 weeks for 12 months
CyclophosphamideDrug
Also called Cytoxan
Once a day for 6 months
MethotrexateDrug
Also called amethopterin
Twice daily for the first two days of every week for 6 months
CapecitabineDrug
Also called Xeloda
Capecitabine: 2000 mg/m2 a day, on Days 1-14 of a 21 day cycle, for at total of 6 cycles (18 weeks)
Bevacizumab: 15 mg/kg IV day 1 every 3 weeks x 1 year (17 cycles)
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Bevacizumab Alone Receives: Drug: Bevacizumab |
| Group B | Experimental | Bevacizumab with cyclophosphamide and methotrexate Receives: Drug: Bevacizumab; Drug: Cyclophosphamide; Drug: Methotrexate |
| Group C | Experimental | capecitabine, 14 days on/7 days off scheduling, and bevacizumab Receives: Drug: Bevacizumab; Drug: Capecitabine |
| Group D | Experimental | capecitabine 7 days on/7 days off scheduling, and bevacizumab Receives: Drug: Bevacizumab; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Completion Rate of 1 Year of Bevacizumab Therapy for All Four Cohorts
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2005 (estimated)
- Study startJun 2005
- Primary completionMay 2009
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harold J. Burstein, MD, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc., Beth Israel Deaconess Medical Center, Indiana University, University of California, San Francisco, University of North Carolina
- Responsible party
- Sponsor-investigator, Harold J. Burstein, MD, PhD, Dana-Farber Cancer Institute
- Investigators
- Harold J Burstein, MD, PhD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00121134
- Sponsor's protocol ID
- 05-055
- Status last verified
- Nov 2013
- First submitted
- 13 Jul 2005
- Last updated
- 24 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Trapani 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.
PubMed 39890560
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-Angiogenesis Treatment After Preoperative Chemotherapy: A Pilot Study in Women With Operable Breast Cancer
- ClinicalTrials.gov ID
- NCT00121134
- Acronym / sponsor ID
- 05-055
- Conditions
- Breast Cancer
- Keywords
- Bevacizumab, Metronomic Chemotherapy, Breast Cancer Stages II-III, Invasive breast cancer stages II-III
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Harold J. Burstein, MD, PhDUniversity, hospital or other
- Collaborators
- Genentech, Inc., Beth Israel Deaconess Medical Center, Indiana University, University of California, San Francisco, University of North Carolina
- Study start
- Jun 2005
- Primary completion
- May 2009 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 21 Jul 2005 (estimated)
- Results
- Posted 14 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This study is broken into 4 groups (A, B, C, and D). Enrollment closed to all groups in May 2008.
The first forty subjects (Group A) in this study were treated with Bevacizumab only, which is given through a vein over 1-2 hours every 3 weeks, for a total of approximately 12 months (17 cycles). Each cycle consists of 3 weeks.
The next forty subjects (Group B) were treated with Bevacizumab and metronomic CM chemotherapy. These subjects took cyclophosphamide (1 pill by mouth every day), methotrexate, (1 pill taken by mouth twice a day for the first two days of each week) and Bevacizumab (once every 3 weeks). The treatments with cyclophosphamide, methotrexate and Bevacizumab will continue for approximately 6 months (8 cycles). Then for the next 6 months, they received Bevacizumab treatments only. The total time on this study will be about 12 months (17 cycles).
The next forty subjects (Group C) were treated with Bevacizumab and Capecitabine chemotherapy. These subjects took Capecitabine pills twice a day for 14 days, then one week of rest, to complete a 21-day cycle. There will be a total of 6 cycles of Capecitabine, meaning 18 weeks of treatment with both Capecitabine and Bevacizumab. Then received Bevacizumab treatments only (11 cycles) to complete 12 months of therapy. Total duration of your treatment will be about 12 months or 17 cycles of therapy.
The last forty subjects (Group D) are being treated with Bevacizumab and Capecitabine chemotherapy on a different schedule. These subjects will take Capecitabine pills twice a day for 7 days, then one week of rest and repeat this for a total of 24 weeks (6 cycles). Each cycle will last for 4 weeks (28 days). There will be a total of 6 cycles of Capecitabine, meaning 24 weeks of treatment with both Capecitabine and Bevacizumab. Bevacizumab will be given every two weeks for a total of 24 weeks (6 cycles). Then they will receive Bevacizumab treatments only, every 3 weeks for additional 27 weeks (9 cycles) to complete 12 months of therapy. For the last 9 cycles of Bevacizumab therapy each cycle will consist of 3 weeks. Total duration of treatment will be about 12 months or 15 cycles of therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: BevacizumabBevacizumab Alone |
| Group B | Experimental | Drug: Bevacizumab, Drug: Cyclophosphamide, Drug: MethotrexateBevacizumab with cyclophosphamide and methotrexate |
| Group C | Experimental | Drug: Bevacizumab, Drug: Capecitabinecapecitabine, 14 days on/7 days off scheduling, and bevacizumab |
| Group D | Experimental | Drug: Bevacizumab, Drug: Capecitabinecapecitabine 7 days on/7 days off scheduling, and bevacizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BevacizumabAlso: AvastinGroup A: Once every 3 weeks for 12 months Group B: Once every 3 weeks for 12 months | Drug | Group A, Group B, Group C, Group D |
| CyclophosphamideAlso: CytoxanOnce a day for 6 months | Drug | Group B |
| MethotrexateAlso: amethopterinTwice daily for the first two days of every week for 6 months | Drug | Group B |
| CapecitabineAlso: XelodaCapecitabine: 2000 mg/m2 a day, on Days 1-14 of a 21 day cycle, for at total of 6 cycles (18 weeks) Bevacizumab: 15 mg/kg IV day 1 every 3 weeks x 1 year (17 cycles) | Drug | Group C, Group D |
Primary outcome
The Completion Rate of 1 Year of Bevacizumab Therapy for All Four Cohorts
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39890560Trapani 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harold J Burstein, MD, PhD principal investigator
Dana-Farber Cancer Institute
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bevacizumab, Cyclophosphamide and Methotrexate in people with Breast Cancer, run by Harold J. Burstein, MD, PhD at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Completion Rate of 1 Year of Bevacizumab Therapy for All Four Cohorts (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00121134, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2013.