Breast CancerPhase 2NCT01321775
Bevacizumab and Trastuzumab With Weekly Paclitaxel Followed, After Surgery, by Encapsuled Liposomal Doxorubicin, Cyclophosphamide and Trastuzumab as Adjuvant Treatment After Surgery on Women With Her2+ Breast Cancer
A Phase 2 study testing Bevacizumab,Trastuzumab,Paclitaxel,Cyclophosphamide,Myocet in people with Breast Cancer, run by Hospital Universitario Madrid Sanchinarro at 3 sites in Spain.
Trial summary
The purpose of this study is to determine the efficacy of the combined therapy Bevacizumab, trastuzumab and paclitaxel in neo-adjuvant therapy in patients with breast cancer HER 2+ followed by surgery and adjuvant therapy (Cyclophosphamide, Trastuzumab and Doxorubicin liposomal). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Bevacizumab,Trastuzumab,Paclitaxel,Cyclophosphamide,Myocet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 3 sitesSpain
- Study dates
- Aug 2009to Nov 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older than 18 years
- Pre or post menopause patient with histology confirmation of breast cancer status II or III, Her2+ confirmed by FISH technique.
- Lesion bigger than 2cm.
- life expectancy > 12 weeks.
- Normal Heart function (LVEF>55%)
- Patient should give his/her signed, written informed consent.
Who cannot join
- Previous chemotherapy treatment.
- Previous treatment with HER2 or VEGF inhibitors.
- Pulmonary disease not controlled.
- Hypertension not controlled (systolic > 150 mmHg and/or diastolic > 100 mmHg) or significant cardiovascular disease (CVA/cerebral hemorrhage (6 months before inclusion), myocardial infarction (6 months before inclusion), unstable angina, congestive cardiac disease ≥ NYHA 2, or serious cardiac arrhythmia requiring medication.
- Antecedents of coagulopathy or clinically significant thrombosis.
- Major surgery, open biopsy or significant trauma 28 days before the inclusion in the study or planned major surgery during the study.
Show all 17Show fewer
- Peripheral Neuropathy > CTC 2 at inclusion.
- Altered renal function a. Creatinine > 2.0 mg/dL or 177 mmol/L. b.Proteinuria > 2+ with reactive stick(dipstick). If screening proteinuria 2+, collection of 24h urine must show a value of proteins of 1 g/24h.
- Daily chronic treatment with corticosteroids
- Daily chronic treatment with aspirin (> 325 mg/day) o clopidogrel (> 75 mg/day)
- Antecedents or heritage evidence of bleeder diathesis or coagulopathy with risk of hemorrhage.
- Antecedents of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months previous to the inclusion.
- Active infection to be treated with iv antibiotics
- Serious injury not curing, peptic ulcer or bone fracture.
- Pregnant or active sexual patient not using contraceptive methods. or lactating woman
- Current or recent treatment with another IMP or participation in another clinical trial (30 days before inclusion)
- Another primary tumor (including primary brain tumors)within 5 years to the study inclusion, apart from in situ cervix carcinoma, skin squamous carcinoma, both if they are appropriately treated, or skin basal cell cancer if controlled.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites, 3 recruiting
- Recruiting
Hospital Ramón Y Cajal
Madrid, Madrid, 28034
Noelia Martinez, MD, 003491 336 80 00, mjnoelia@hotmail.com
Noelia Martinez, MD
- Recruiting
Hospital Universitario
Madrid, Madrid, 28050
Laura Garcia, MD, 003491 756 78 50, lauraestevez@hospitaldemadrid.com
Laura Garcia, MD
- Recruiting
Complejo Hospital Costa Del
Marbella, Malaga, 29600
Diego Perez, MD, 0034951 97 66 69, dipema2026@gmail.com
Diego Perez, MD
About this study
Official title: Bevacizumab and Trastuzumab With Paclitaxel on Women With Her2+ Breast Cancer Weekly Paclitaxel Followed, After Surgery, by Encapsuled Liposomal Doxorubicin, Cyclophosphamide and Trastuzumab as Adjuvant Treatment After Surgery on Women With Her2+ Breast Cancer
The purpose of this study is to determine the efficacy of the combined therapy Bevacizumab, trastuzumab and paclitaxel in neo-adjuvant therapy in patients with breast cancer HER 2+ followed by surgery and adjuvant therapy (Cyclophosphamide, Trastuzumab and Doxorubicin liposomal).
- Conditions
- Breast Cancer
- Being tested
- Bevacizumab,Trastuzumab,Paclitaxel,Cyclophosphamide,Myocet
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bevacizumab,Trastuzumab,Paclitaxel,Cyclophosphamide,MyocetDrug
Neo-adjuvant doses (12 weeks):
Bevacizumab: 15mg/Kg every 3 weeks Trastuzumab: 4 mg/Kg (First dose) - 2mg/Kg every week. Paclitaxel: 80mg/m2 every week.
Adjuvant doses:
Trastuzumab: 8mg/Kg(first dose)- 6mg/Kg every 3 weeks (At least 9 months) Cyclophosphamide: 600mg/m2 every 3 weeks (9 months) Doxorubicin Liposomal: 50mg/m2 every 3 weeks (3 months)
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab,Trastuzumab,Paclitaxel,Cyclophosphamide,Myocet | Experimental | Not described Receives: Drug: Bevacizumab,Trastuzumab,Paclitaxel,Cyclophosphamide,Myocet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic response in breast and axilla
Measured: 16 weeks average
Secondary outcomes (1)
To evaluate tumor markers as potential predictors of the pathologic response
Measured: baseline and 16 weeks average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2011 (estimated)
- Study startAug 2009
- Primary completionFeb 2013 (estimated)
- Study completionNov 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Madrid Sanchinarro
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01321775
- Sponsor's protocol ID
- AVANTHER
- Status last verified
- Jun 2010
- First submitted
- 23 Mar 2011
- Last updated
- 24 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bevacizumab and Trastuzumab With Paclitaxel on Women With Her2+ Breast Cancer Weekly Paclitaxel Followed, After Surgery, by Encapsuled Liposomal Doxorubicin, Cyclophosphamide and Trastuzumab as Adjuvant Treatment After Surgery on Women With Her2+ Breast Cancer
- ClinicalTrials.gov ID
- NCT01321775
- Acronym / sponsor ID
- AVANTHER
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Hospital Universitario Madrid SanchinarroUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Feb 2013 (estimated)
- Study completion
- Nov 2013 (estimated)
- First posted
- 24 Mar 2011 (estimated)
- Results
- Not posted in the source record
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 study is to determine the efficacy of the combined therapy Bevacizumab, trastuzumab and paclitaxel in neo-adjuvant therapy in patients with breast cancer HER 2+ followed by surgery and adjuvant therapy (Cyclophosphamide, Trastuzumab and Doxorubicin liposomal).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab,Trastuzumab,Paclitaxel,Cyclophosphamide,Myocet | Experimental | Drug: Bevacizumab,Trastuzumab,Paclitaxel,Cyclophosphamide,Myocet |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Older than 18 years
- Pre or post menopause patient with histology confirmation of breast cancer status II or III, Her2+ confirmed by FISH technique.
- Lesion bigger than 2cm.
- life expectancy > 12 weeks.
- Normal Heart function (LVEF>55%)
Key exclusion criteria (17 listed)
- Previous chemotherapy treatment.
- Previous treatment with HER2 or VEGF inhibitors.
- Pulmonary disease not controlled.
- Hypertension not controlled (systolic > 150 mmHg and/or diastolic > 100 mmHg) or significant cardiovascular disease (CVA/cerebral hemorrhage (6 months before inclusion), myocardial infarction (6 months before inclusion), unstable angina, congestive cardiac disease ≥ NYHA 2, or serious cardiac arrhythmia requiring medication.
- Antecedents of coagulopathy or clinically significant thrombosis.
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 |
|---|---|---|
| Bevacizumab,Trastuzumab,Paclitaxel,Cyclophosphamide,MyocetNeo-adjuvant doses (12 weeks): Bevacizumab: 15mg/Kg every 3 weeks Trastuzumab: 4 mg/Kg (First dose) - 2mg/Kg every week. Paclitaxel: 80mg/m2 every week. Adjuvant doses: Trastuzumab: 8mg/Kg(first dose)- 6mg/Kg every 3 weeks (At least 9 months) Cyclophosphamide: 600mg/m2 every 3 weeks (9 months) Doxorubicin Liposomal: 50mg/m2 every 3 weeks (3 months) | Drug | Bevacizumab,Trastuzumab,Paclitaxel,Cyclophosphamide,Myocet |
Primary outcome
Pathologic response in breast and axilla
Time frame: 16 weeks average
1 secondary outcome
To evaluate tumor markers as potential predictors of the pathologic response
Time frame: baseline and 16 weeks average
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2011.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevacizumab,Trastuzumab,Paclitaxel,Cyclophosphamide,Myocet in people with Breast Cancer, run by Hospital Universitario Madrid Sanchinarro at 3 sites in Spain.
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 6 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 24 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic response in breast and axilla (time frame: 16 weeks average). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2011.