Breast CancerPhase 2NCT00559845
A Study of Avastin (Bevacizumab) in Patients With Inflammatory or Locally Advanced Breast Cancer
A Phase 2 study testing 5-fluorouracil, Epidoxorubicin and Cyclophosphamide in people with Breast Cancer, run by Hoffmann-La Roche at 8 sites in Italy.
Trial summary
This single arm study will assess the efficacy and safety of sequential neoadjuvant chemotherapy and bevacizumab (Avastin), before surgery and/or radiotherapy, in participants with inflammatory or locally advanced operable breast cancer. 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?
- 5-fluorouracil, Epidoxorubicin and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 8 sitesItaly
- Study dates
- Feb 2008to Jul 2015
- Phase
- Phase 2
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female participants, >=18 years of age;
- stage III, or inflammatory breast cancer;
- estrogen receptor/progesterone receptor (ER/PgR) positive or negative and human epidermal growth factor receptor 2 (HER-2) negative;
- normal left ventricular ejection fraction (LVEF).
Who cannot join
- previous chemotherapy/endocrine therapy;
- evidence of distant metastatic disease;
- other primary tumors in last 5 years (except for adequately treated cancer in situ of the cervix, or basal cell skin cancer);
- chronic daily treatment with >325 milligram per day (mg/day) aspirin, or >75mg/day clopidogrel.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Italy8 sites
Study site
Cuneo, Piedmont, 12100
Study site
Genoa, Liguria, 16132
Study site
Mantua, Lombardy, 46100
Study site
Naples, Campania, 80131
Study site
Negrar, Veneto, 37024
Study site
Pordenone, Friuli Venezia Giulia, 33170
Study site
Reggio Emilia, Emilia-Romagna, 42100
Study site
Turin, Piedmont, 10126
About this study
Official title: Phase II, Open Label, Neoadjuvant Study of Bevacizumab in Patients With Inflammatory or Locally Advanced Breast Cancer
This single arm study will assess the efficacy and safety of sequential neoadjuvant chemotherapy and bevacizumab (Avastin), before surgery and/or radiotherapy, in participants with inflammatory or locally advanced operable breast cancer. Participants will receive 5-fluorouracil, epidoxorubicin and cyclophosphamide (FEC), followed by paclitaxel, given concomitantly with bevacizumab. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
- Conditions
- Breast Cancer
- Being tested
- 5-fluorouracil, Epidoxorubicin, Cyclophosphamide, Paclitaxel, Bevacizumab
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-fluorouracilDrug
600 milligrams per meter squared (mg/m^2) as an intravenous (i.v.) bolus over ≤15 minutes every 3 weeks for 4 cycles.
EpidoxorubicinDrug
90 mg/m^2 as an i.v. infusion over 1 hour every 3 weeks for 4 cycles.
CyclophosphamideDrug
600 mg/m^2 as an i.v. infusion over 1 hour every 3 weeks for 4 cycles.
PaclitaxelDrug
Paclitaxel was administered at 80 mg/m^2 i.v. over 1 hour weekly for 12 weeks.
BevacizumabBiological
Also called Avastin®
Bevacizumab was administered at 10 milligrams per kilogram (mg/kg) i.v. every 2 weeks for 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab | Experimental | Participants will receive FEC, followed by paclitaxel, given concomitantly with bevacizumab for approximately 3-12 months. Receives: Drug: 5-fluorouracil; Drug: Epidoxorubicin; Drug: Cyclophosphamide; Drug: Paclitaxel; Biological: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Pathological Complete Response Following Principle Investigator Review
Pathological complete response was defined as absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy.
Measured: Up to 7.5 years
Secondary outcomes (5)
Objective Response Rate
Objective response rate was defined as the percentage of participants with a Complete Response (CR) or Partial Response (PR) as defined by the Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as the disappearance of all target lesions; PR was defined as a 30% decrease in sum of longest diameter of target lesions.
Measured: Up to 7.5 years
Percentage of Participants With Breast-Conserving Surgery
Rate of breast conversing surgery is defined as percentage of participants who achieved breast conversing surgery out of the ITT population without inflammatory breast cancer, as these participants received mastectomy irrespective of their response to neoadjuvant treatment.
Measured: Up to 7.5 years
Percentage of Participants With Disease-Free Interval
Disease-free interval was defined as the time from enrollment until recurrence of tumor or death from any cause, and was estimated using the Kaplan-Meier method. The percentage of participants without events at Months 12, 24, 36, 48, and 60 is presented.
Measured: Months 12, 24, 36, 48, and 60
Overall Survival
Overall survival was defined as the time from enrollment of participant to death from any cause.
Measured: Up to 7.5 years
Percentage of Participants Experiencing Any Adverse Event
An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Measured: Up to 7.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2007 (estimated)
- Study startFeb 2008
- Primary completionJul 2015
- Study completionJul 2015
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.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- 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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00559845
- Sponsor's protocol ID
- ML19884
- Other IDs
- 2006-003291-35
- Status last verified
- Oct 2016
- First submitted
- 15 Nov 2007
- Last updated
- 9 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Clavarezza M, Turazza M, Aitini E, Saracchini S, Garrone O, Durando A, De Placido S, Bisagni G, Levaggi A, Bighin C, Restuccia E, Scalamogna R, Galli A, Del Mastro L. Phase II open-label study of bevacizumab combined with neoadjuvant anthracycline and taxane therapy for locally advanced breast cancer. Breast. 2013 Aug;22(4):470-5. doi: 10.1016/j.breast.2013.03.012. Epub 2013 May 1.
PubMed 23642526
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Open Label, Neoadjuvant Study of Bevacizumab in Patients With Inflammatory or Locally Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT00559845
- Acronym / sponsor ID
- ML19884
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 16 Nov 2007 (estimated)
- Results
- Posted 9 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single arm study will assess the efficacy and safety of sequential neoadjuvant chemotherapy and bevacizumab (Avastin), before surgery and/or radiotherapy, in participants with inflammatory or locally advanced operable breast cancer. Participants will receive 5-fluorouracil, epidoxorubicin and cyclophosphamide (FEC), followed by paclitaxel, given concomitantly with bevacizumab. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab | Experimental | Drug: 5-fluorouracil, Drug: Epidoxorubicin, Drug: Cyclophosphamide, Drug: Paclitaxel, Biological: BevacizumabParticipants will receive FEC, followed by paclitaxel, given concomitantly with bevacizumab for approximately 3-12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- female participants, >=18 years of age;
- stage III, or inflammatory breast cancer;
- estrogen receptor/progesterone receptor (ER/PgR) positive or negative and human epidermal growth factor receptor 2 (HER-2) negative;
- normal left ventricular ejection fraction (LVEF).
Key exclusion criteria (4 listed)
- previous chemotherapy/endocrine therapy;
- evidence of distant metastatic disease;
- other primary tumors in last 5 years (except for adequately treated cancer in situ of the cervix, or basal cell skin cancer);
- chronic daily treatment with >325 milligram per day (mg/day) aspirin, or >75mg/day clopidogrel.
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 |
|---|---|---|
| 5-fluorouracil600 milligrams per meter squared (mg/m^2) as an intravenous (i.v.) bolus over ≤15 minutes every 3 weeks for 4 cycles. | Drug | Bevacizumab |
| Epidoxorubicin90 mg/m^2 as an i.v. infusion over 1 hour every 3 weeks for 4 cycles. | Drug | Bevacizumab |
| Cyclophosphamide600 mg/m^2 as an i.v. infusion over 1 hour every 3 weeks for 4 cycles. | Drug | Bevacizumab |
| PaclitaxelPaclitaxel was administered at 80 mg/m^2 i.v. over 1 hour weekly for 12 weeks. | Drug | Bevacizumab |
| BevacizumabAlso: Avastin®Bevacizumab was administered at 10 milligrams per kilogram (mg/kg) i.v. every 2 weeks for 6 cycles. | Biological | Bevacizumab |
Primary outcome
Percentage of Participants With Pathological Complete Response Following Principle Investigator Review
Time frame: Up to 7.5 years
Pathological complete response was defined as absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy.
5 secondary outcomes
Objective Response Rate
Time frame: Up to 7.5 years
Percentage of Participants With Breast-Conserving Surgery
Time frame: Up to 7.5 years
Percentage of Participants With Disease-Free Interval
Time frame: Months 12, 24, 36, 48, and 60
Overall Survival
Time frame: Up to 7.5 years
Percentage of Participants Experiencing Any Adverse Event
Time frame: Up to 7.5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23642526Clavarezza M, Turazza M, Aitini E, Saracchini S, Garrone O, Durando A, De Placido S, Bisagni G, Levaggi A, Bighin C, Restuccia E, Scalamogna R, Galli A, Del Mastro L. Phase II open-label study of bevacizumab combined with neoadjuvant anthracycline and taxane therapy for locally advanced breast cancer. Breast. 2013 Aug;22(4):470-5. doi: 10.1016/j.breast.2013.03.012. Epub 2013 May 1.
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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.
Clinical Trials study director
Hoffmann-La Roche
8 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 5-fluorouracil, Epidoxorubicin and Cyclophosphamide in people with Breast Cancer, run by Hoffmann-La Roche at 8 sites in Italy.
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 4 inclusion and 4 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 9 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Italy. 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?
Yes. Results are posted in the registry (first posted 9 Apr 2018). 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?
Percentage of Participants With Pathological Complete Response Following Principle Investigator Review (time frame: Up to 7.5 years). 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 NCT00559845, 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 9 Apr 2018.