Metastatic Breast CancerPhase 3NCT00262067
A Study Evaluating the Efficacy and Safety of Bevacizumab in Combination With Chemotherapy in Untreated Metastatic Breast Cancer (RIBBON 1)
A Phase 3 study testing Bevacizumab and Chemotherapy in people with Metastatic Breast Cancer, run by Genentech, Inc. at 92 sites in 22 countries.
Trial summary
This is a Phase III, multicenter, randomized, placebo-controlled trial designed to evaluate the efficacy and safety of bevacizumab in combination with chemotherapy compared with chemotherapy alone in subjects with previously untreated metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Bevacizumab and Chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,237 participants
- Where
- 92 sitesin 22 countries
- Study dates
- Dec 2005to Dec 2013
- Phase
- Phase 3
- 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 adenocarcinoma of the breast, with measurable or non-measurable locally recurrent or metastatic disease.
- Signed Informed Consent Form.
- Age ≥ 18 years.
- For women of childbearing potential, use of accepted and effective method of non-hormonal contraception.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Ability and capacity to comply with study and follow-up procedures.
- For anthracycline cohort only: Adequate left ventricular function at study entry, defined as a left ventricular ejection fraction (LVEF) ≥ 50% by either multigated acquisition (MUGA) scan scan or echocardiography (ECHO).
- For subjects who have received recent radiation therapy, recovery prior to baseline (Day 0) from any significant (Grade ≥ 3) acute toxicity.
Who cannot join
- Unknown human epidermal growth factor receptor 2 (HER2) status or known HER2-positive status.
- Prior chemotherapy for locally recurrent or metastatic disease.
- Prior hormonal therapy less than 1 week prior to Day 0.
- Prior adjuvant or neoadjuvant chemotherapy within 12 months prior to Day 0.
- For anthracycline cohort only: Prior anthracycline as part of neoadjuvant or adjuvant therapy for localized breast cancer.
- Investigational therapy within 28 days of Day 0.
Show all 24Show fewer
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, or anticipation of need for major surgical procedure during the course of the study.
- Minor surgical procedures, such as fine needle aspirations or core biopsies, within 7 days prior to Day 0.
- Prior therapy with bevacizumab, sorafenib, sunitinib, or other vascular endothelial growth factor (VEGF) pathway-targeted therapy.
- Known brain or other central nervous system (CNS) metastases.
- Blood pressure of > 150/100 mmHg.
- Unstable angina.
- New York Heart Association (NYHA) Grade II or greater congestive heart failure (CHF).
- History of myocardial infarction within 6 months prior to Day 0.
- History of stroke or transient ischemic attack within 6 months prior to Day 0.
- Clinically significant peripheral vascular disease.
- Evidence of bleeding diathesis or coagulopathy.
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0.
- Serious non-healing wound, ulcer, or bone fracture.
- Pregnancy (positive serum pregnancy test) or lactation.
- Inadequate organ function, as evidenced by any of the following laboratory values: Absolute neutrophil count < 1500/uL; platelet count < 100,000/uL; total bilirubin > 1.5 mg/dL; alkaline phosphatase, AST, and/or ALT > 2x upper limit of normal (ULN) (> 5x ULN in subjects with known liver or, for alkaline phosphatase elevations, bone involvement); alkaline phosphatase > 2x ULN (> 7x ULN in subjects with known bone involvement); serum creatinine > 2.0 mg/dL; partial thromboplastin time (PTT) and/or either international normalized ratio (INR) or prothrombin time (PT) > 1.5x upper limit of normal (except for subjects receiving anti-coagulation therapy); urine protein/creatinine ratio > 1.0 at screening for U.S. subjects, or urine dipstick for proteinuria >/= 1+ at screening followed by 24-hour urine collection demonstrating > 1 g protein/24 hr for ex-U.S. subjects.
- Uncontrolled serious medical or psychiatric illness.
- Active infection requiring intravenous (iv) antibiotics at Day 0.
- History of other malignancies within 5 years of Day 0 except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal cell carcinoma or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix (subjects with a history of bilateral breast cancer will be eligible).
Trial locations and contacts
92 sites in 22 countries.
92 sites in 22 countries
Russia13 sites
Study site
Chelyabinsk, 454 087
Study site
Ivanovo, 153040
Study site
Kazan', 420029
Study site
Kazan', 420111
Study site
Moscow, 115478
Study site
Moscow, 117837
Study site
Moscow, 129128
Study site
Novosibirsk, 630047
Study site
Obninsk, 249036
Study site
Ryazan, 390011
Study site
Saint Petersburg, 197758
Study site
Samara, 443066
Study site
Ufa, 450054
Spain10 sites
Study site
A Coruña, 15006
Study site
Córdoba, 14004
Study site
Elche, 03203
Study site
Girona, 17007
Study site
Madrid, 28034
Study site
San Cristóbal de La Laguna, 38320
Study site
Santander, 39008
Study site
Seville, 41013
Study site
Valencia, 46010
Study site
Zaragoza, 50009
Australia8 sites
Study site
Geelong, 3220
Study site
Malvern, 3144
Study site
Melbourne, 3002
Study site
Perth, 6008
Study site
Southport, 4215
Study site
Wahroonga, 2076
Study site
Waratah, 2298
Study site
Wollongong, 2500
United Kingdom7 sites
Study site
Chelsmford, CM1 7ET
Study site
Cottingham, HU16 5JQ
Study site
Epping, CM16 6TN
Study site
Huddersfield, HD3 3EA
Study site
Nottingham, NG5 1PB
Study site
Sheffield, S1O 2SJ
Study site
Swansea, SA2 8QA
Ukraine6 sites
Study site
Cherkassy, 18009
Study site
Dnipropetrovsk, 49102
Study site
Kiev, 03115
Study site
Lviv, 79031
Study site
Odesa, 65055
Study site
Zaporizhzhya, 69104
United States5 sites
Study site
Fullerton, California, 92835
Study site
Iowa City, Iowa, 52242
Study site
Santa Barbara, California, 93105
Study site
Sioux City, Iowa, 51101
Study site
Wichita, Kansas, 67214-3728
Brazil5 sites
Study site
Porto Alegre, 91350-200
Study site
Rio de Janeiro, 22260-020
Study site
Salvador, 40170-110
Study site
Santo André, 09060-870
Study site
São Paulo, 03102-002
France5 sites
Study site
Marseille, 13273
Study site
Paris, 75248
Study site
Reims, 51100
Study site
Saint-Herblain, 44805
Study site
Strasbourg, 67010
Greece5 sites
Study site
Athens, 11521
Study site
Chania, 73300
Study site
Heraklion, 71110
Study site
Pátrai, 26500
Study site
Thessaloniki, 57001
Mexico5 sites
Study site
Acapulco, 39670
Study site
Aguascalientes, 20230
Study site
Mérida, 97500
Study site
Monterrey, 64020
Study site
Monterrey, 64380
Canada3 sites
Study site
Montreal, Quebec, H2L 4M1
Study site
Montreal, Quebec, H2W 1S6
Study site
Winnipeg, Manitoba, R2H 2A6
Netherlands3 sites
Study site
Amstelveen, 1186 AH
Study site
Apeldoorn, 7334 DZ
Study site
Delft, 2600 GA
South Korea3 sites
Study site
Kyunggi-do, 411-769
Study site
Seoul, 110-744
Study site
Seoul, 120-752
Sweden3 sites
Study site
Gävle, 80187
Study site
Örebro, 701 85
Study site
Uppsala, 751 85
About this study
Official title: A Multicenter, Phase III, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of Bevacizumab in Combination With Chemotherapy Regimens in Subjects With Previously Untreated Metastatic Breast Cancer
This is a Phase III, multicenter, randomized, placebo-controlled trial designed to evaluate the efficacy and safety of bevacizumab in combination with chemotherapy compared with chemotherapy alone in subjects with previously untreated metastatic breast cancer.
Read the detailed description
This study includes a blinded treatment phase, an optional open-label post-progression phase, and a survival follow-up phase. During the blinded treatment phase, patients receive chemotherapy and study drug (bevacizumab or placebo) every 3 weeks until disease progression, treatment-limiting toxicity, or death due to any cause. The optional open-label post-progression phase consists of chemotherapy treatment (per investigator discretion) and optional treatment with open-label bevacizumab. Patients who complete the study or who discontinue from treatment (regardless of participation in the optional open-label post-progression phase) will be followed for survival and subsequent anti-cancer therapies every 4 months until death, withdrawal of consent, loss to follow-up, or study termination. Patients who discontinue from treatment during the blinded treatment phase for reasons other than disease progression will have tumor assessments every 9 weeks until documented disease progression or death.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Bevacizumab, Placebo, Chemotherapy
- 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
Patients received bevacizumab until disease progression, treatment limiting toxicity, or death due to any cause up to a maximum treatment duration of 48 months. The dose of bevacizumab was based on the patient's weight at either screening or baseline and remained the same throughout the blinded treatment phase of the study. The initial dose was delivered over 90±10 minutes. If there were no infusion related adverse events (fever and/or chills), the second infusion was delivered over 60±10 minutes. If the 60 minute infusion was well tolerated, all subsequent infusions were delivered over 30±10 minutes.
PlaceboDrug
Placebo consisted of the vehicle for bevacizumab without the antibody.
ChemotherapyDrug
The chemotherapy was selected by the investigator prior to randomization. Chemotherapy treatment continued until disease progression, unacceptable toxicity, investigator/patient decision, or death, whichever occurred first, except for the anthracycline-based regimens, which had a maximum treatment duration of 8 cycles.
Taxanes - 1 of the following 2 taxanes on Day 1 of every 21-day cycle
- Docetaxel 75-100 mg/m^2 IV
- Paclitaxel protein-bound particles (Abraxane®) 260 mg/m^2 IV
Anthracyclines - 1 of the following 4 anthracycline-based regimens on Day 1 of every 21-day cycle
- 5-fluorouracil 500 mg/m^2 IV + epirubicin 90-100 mg/m^2 IV + cyclophosphamide 500 mg/m^2 IV
- 5-fluorouracil 500 mg/m^2 IV + doxorubicin 50 mg/m^2 IV + cyclophosphamide 500 mg/m^2 IV
- Doxorubicin 50-60 mg/m^2 IV + cyclophosphamide 500-600 mg/m^2 IV
- Epirubicin 90-100 mg/m^2 IV + cyclophosphamide 500-600 mg/m^2 IV
Capecitabine: 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day cycle
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab + chemotherapy | Experimental | Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle plus one of several standard chemotherapies (taxanes, anthracycline-based regimens, or capecitabine) for metastatic breast cancer. Receives: Drug: Bevacizumab; Drug: Chemotherapy |
| Placebo + chemotherapy | Placebo comparator | Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + 1 of several standard chemotherapies (taxanes, anthracycline-based regimens, or capecitabine) for metastatic breast cancer. Receives: Drug: Placebo; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)
PFS was defined as the time from randomization to first documented disease progression (PD) as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) or death due to any cause, whichever occurred first. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Target lesions should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements by imaging techniques or clinically. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions.
Measured: Baseline to the data cut-off date of 31 Jul 2008 (up to 2 years, 7 months)
Secondary outcomes (5)
Objective Response as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)
An objective response was defined as a complete response or a partial response determined on two consecutive occasions ≥ 4 weeks apart as determined by the investigator using RECIST. For target lesions, a complete response was defined as the disappearance of all target lesions; a partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. For non-target lesions, a complete response was defined as the disappearance of all non-target lesions; a partial response was defined as the persistence of 1 or more non-target lesions.
Measured: Baseline to the data cut-off date of 31 Jul 2008 (up to 2 years, 7 months)
Duration of Objective Response as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)
Duration of objective response was defined as the time from the first tumor assessment that led to a determination of an objective response to the time of disease progression or death due to any cause, whichever occurred first.
Measured: Baseline to the data cut-off date of 31 Jul 2008 (up to 2 years, 7 months)
Overall Survival
Overall survival was defined as the time from randomization until death from any cause.
Measured: Baseline to the data cut-off of 23 Feb 2009 (up to 3 years, 2 months)
1-year Survival
1-year survival was defined as the percentage of patients who were alive 1 year after randomization.
The percentage of patients alive at 1 year was determined using Kaplan-Meier analyses and the 95% confidence intervals were computed using the Brookmeyer-Crowley method.
Measured: Baseline to the data cut-off of 23 Feb 2009 (up to 3 years, 2 months)
Progression-free Survival (PFS) as Determined by the Independent Review Committee Using Response Evaluation Criteria in Solid Tumors (RECIST)
PFS was defined as the time from randomization to first documented disease progression (PD) as determined by the Independent Review Committee using Response Evaluation Criteria in Solid Tumors (RECIST) or death due to any cause, whichever occurred first.
Measured: Baseline to the data cut-off date of 31 Jul 2008 (up to 2 years, 7 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2005 (estimated)
- Study startDec 2005
- Primary completionJul 2008
- Study completionDec 2013 (estimated)
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 Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,237 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leonardo Faoro, MD, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00262067
- Sponsor's protocol ID
- AVF3694g
- Other IDs
- BO20094
- Status last verified
- Nov 2013
- First submitted
- 2 Dec 2005
- Last updated
- 13 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Wedam SB, Beaver JA, Amiri-Kordestani L, Bloomquist E, Tang S, Goldberg KB, Sridhara R, Ibrahim A, Kim G, Kluetz P, McKee A, Pazdur R. US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-Only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments. J Clin Oncol. 2018 Apr 20;36(12):1225-1231. doi: 10.1200/JCO.2017.74.6917. Epub 2018 Mar 9.
PubMed 29522361
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Phase III, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of Bevacizumab in Combination With Chemotherapy Regimens in Subjects With Previously Untreated Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00262067
- Acronym / sponsor ID
- AVF3694g
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,237 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Jul 2008 (actual)
- Study completion
- Dec 2013 (estimated)
- First posted
- 6 Dec 2005 (estimated)
- Results
- Posted 25 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase III, multicenter, randomized, placebo-controlled trial designed to evaluate the efficacy and safety of bevacizumab in combination with chemotherapy compared with chemotherapy alone in subjects with previously untreated metastatic breast cancer.
Detailed description
This study includes a blinded treatment phase, an optional open-label post-progression phase, and a survival follow-up phase. During the blinded treatment phase, patients receive chemotherapy and study drug (bevacizumab or placebo) every 3 weeks until disease progression, treatment-limiting toxicity, or death due to any cause. The optional open-label post-progression phase consists of chemotherapy treatment (per investigator discretion) and optional treatment with open-label bevacizumab. Patients who complete the study or who discontinue from treatment (regardless of participation in the optional open-label post-progression phase) will be followed for survival and subsequent anti-cancer therapies every 4 months until death, withdrawal of consent, loss to follow-up, or study termination. Patients who discontinue from treatment during the blinded treatment phase for reasons other than disease progression will have tumor assessments every 9 weeks until documented disease progression or death.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab + chemotherapy | Experimental | Drug: Bevacizumab, Drug: ChemotherapyPatients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle plus one of several standard chemotherapies (taxanes, anthracycline-based regimens, or capecitabine) for metastatic breast cancer. |
| Placebo + chemotherapy | Placebo comparator | Drug: Placebo, Drug: ChemotherapyPatients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + 1 of several standard chemotherapies (taxanes, anthracycline-based regimens, or capecitabine) for metastatic breast cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically or cytologically confirmed adenocarcinoma of the breast, with measurable or non-measurable locally recurrent or metastatic disease.
- Signed Informed Consent Form.
- Age ≥ 18 years.
- For women of childbearing potential, use of accepted and effective method of non-hormonal contraception.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Key exclusion criteria (24 listed)
- Unknown human epidermal growth factor receptor 2 (HER2) status or known HER2-positive status.
- Prior chemotherapy for locally recurrent or metastatic disease.
- Prior hormonal therapy less than 1 week prior to Day 0.
- Prior adjuvant or neoadjuvant chemotherapy within 12 months prior to Day 0.
- For anthracycline cohort only: Prior anthracycline as part of neoadjuvant or adjuvant therapy for localized breast cancer.
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: AvastinPatients received bevacizumab until disease progression, treatment limiting toxicity, or death due to any cause up to a maximum treatment duration of 48 months. The dose of bevacizumab was based on the patient's weight at either screening or baseline and remained the same throughout the blinded treatment phase of the study. The initial dose was delivered over 90±10 minutes. If there were no infusion related adverse events (fever and/or chills), the second infusion was delivered over 60±10 minutes. If the 60 minute infusion was well tolerated, all subsequent infusions were delivered over 30±10 minutes. | Drug | Bevacizumab + chemotherapy |
| PlaceboPlacebo consisted of the vehicle for bevacizumab without the antibody. | Drug | Placebo + chemotherapy |
| ChemotherapyThe chemotherapy was selected by the investigator prior to randomization. Chemotherapy treatment continued until disease progression, unacceptable toxicity, investigator/patient decision, or death, whichever occurred first, except for the anthracycline-based regimens, which had a maximum treatment duration of 8 cycles. Taxanes - 1 of the following 2 taxanes on Day 1 of every 21-day cycle 1. Docetaxel 75-100 mg/m^2 IV 2. Paclitaxel protein-bound particles (Abraxane®) 260 mg/m^2 IV Anthracyclines - 1 of the following 4 anthracycline-based regimens on Day 1 of every 21-day cycle 1. 5-fluorouracil 500 mg/m^2 IV + epirubicin 90-100 mg/m^2 IV + cyclophosphamide 500 mg/m^2 IV 2. 5-fluorouracil 500 mg/m^2 IV + doxorubicin 50 mg/m^2 IV + cyclophosphamide 500 mg/m^2 IV 3. Doxorubicin 50-60 mg/m^2 IV + cyclophosphamide 500-600 mg/m^2 IV 4. Epirubicin 90-100 mg/m^2 IV + cyclophosphamide 500-600 mg/m^2 IV Capecitabine: 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day cycle | Drug | Bevacizumab + chemotherapy, Placebo + chemotherapy |
Primary outcome
Progression-free Survival (PFS) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: Baseline to the data cut-off date of 31 Jul 2008 (up to 2 years, 7 months)
PFS was defined as the time from randomization to first documented disease progression (PD) as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) or death due to any cause, whichever occurred first. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Target lesions should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements by imaging techniques or clinically. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions.
5 secondary outcomes
Objective Response as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: Baseline to the data cut-off date of 31 Jul 2008 (up to 2 years, 7 months)
Duration of Objective Response as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: Baseline to the data cut-off date of 31 Jul 2008 (up to 2 years, 7 months)
Overall Survival
Time frame: Baseline to the data cut-off of 23 Feb 2009 (up to 3 years, 2 months)
1-year Survival
Time frame: Baseline to the data cut-off of 23 Feb 2009 (up to 3 years, 2 months)
Progression-free Survival (PFS) as Determined by the Independent Review Committee Using Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: Baseline to the data cut-off date of 31 Jul 2008 (up to 2 years, 7 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29522361Wedam SB, Beaver JA, Amiri-Kordestani L, Bloomquist E, Tang S, Goldberg KB, Sridhara R, Ibrahim A, Kim G, Kluetz P, McKee A, Pazdur R. US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-Only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments. J Clin Oncol. 2018 Apr 20;36(12):1225-1231. doi: 10.1200/JCO.2017.74.6917. Epub 2018 Mar 9.
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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.
Leonardo Faoro, MD study director
Genentech, Inc.
92 sites in 22 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bevacizumab and Chemotherapy in people with Metastatic Breast Cancer, run by Genentech, Inc. at 92 sites in 22 countries.
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 8 inclusion and 24 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 13 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 92 sites in Russia, Spain, Australia, United Kingdom, Ukraine and 17 more countries. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 25 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?
Progression-free Survival (PFS) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) (time frame: Baseline to the data cut-off date of 31 Jul 2008 (up to 2 years, 7 months)). 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 NCT00262067, 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 13 Dec 2013.