A Study Evaluating the Efficacy and Safety of Bevacizumab in Combination With Chemotherapy in Untreated Metastatic Breast Cancer (RIBBON 1)

Phase

Condition

Breast Cancer

Metastatic Cancer

Treatment

N/A

Clinical Study ID

NCT00262067

AVF3694g

BO20094

Ages > 18
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Histologically or cytologically confirmed adenocarcinoma of the breast, withmeasurable 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 ofnon-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 multigatedacquisition (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.

Exclusion

Exclusion Criteria:

Unknown human epidermal growth factor receptor 2 (HER2) status or known HER2-positivestatus.
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 adjuvanttherapy for localized breast cancer.
Investigational therapy within 28 days of Day 0.
Major surgical procedure, open biopsy, or significant traumatic injury within 28 daysprior to Day 0, or anticipation of need for major surgical procedure during the courseof the study.
Minor surgical procedures, such as fine needle aspirations or core biopsies, within 7days prior to Day 0.
Prior therapy with bevacizumab, sorafenib, sunitinib, or other vascular endothelialgrowth 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 abscesswithin 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, boneinvolvement); alkaline phosphatase > 2x ULN (> 7x ULN in subjects with known boneinvolvement); serum creatinine > 2.0 mg/dL; partial thromboplastin time (PTT) and/oreither international normalized ratio (INR) or prothrombin time (PT) > 1.5x upperlimit of normal (except for subjects receiving anti-coagulation therapy); urineprotein/creatinine ratio > 1.0 at screening for U.S. subjects, or urine dipstick forproteinuria >/= 1+ at screening followed by 24-hour urine collection demonstrating > 1g 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 anegligible risk for metastasis or death, such as adequately controlled basal cellcarcinoma 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).

Study Design

December 01, 2005

December 31, 2013

Study 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.

Connect with a study center

Geelong, 3220
Australia
Site Not Available
Malvern, 3144
Australia
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Melbourne, 3002
Australia
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Perth, 6008
Australia
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Southport, 4215
Australia
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Wahroonga, 2076
Australia
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Waratah, 2298
Australia
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Wollongong, 2500
Australia
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Porto Alegre, 91350-200
Brazil
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Rio de Janeiro, 22260-020
Brazil
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Salvador, 40170-110
Brazil
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Santo Andre, 09060-870
Brazil
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Sao Paulo, 03102-002
Brazil
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Winnipeg, Manitoba R2H 2A6
Canada
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Montreal, Quebec H2W 1S6
Canada
Site Not Available
Marseille, 13273
France
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Paris, 75248
France
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Reims, 51100
France
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Saint Herblain, 44805
France
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Strasbourg, 67010
France
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Athens, 11521
Greece
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Hania, 73300
Greece
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Heraklion, 71110
Greece
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Patras, 26500
Greece
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Thessaloniki, 57001
Greece
Site Not Available
Guatemala City, 01015
Guatemala
Site Not Available
Kyunggi-do, 411-769
Korea, Republic of
Site Not Available
Seoul, 120-752
Korea, Republic of
Site Not Available
Acapulco, 39670
Mexico
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Aguascalientes, 20230
Mexico
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Merida, 97500
Mexico
Site Not Available
Monterrey, 64380
Mexico
Site Not Available
Amstelveen, 1186 AH
Netherlands
Site Not Available
Apeldoorn, 7334 DZ
Netherlands
Site Not Available
Delft, 2600 GA
Netherlands
Site Not Available
Oslo, 0310
Norway
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Panama City,
Panama
Site Not Available
Callao,
Peru
Site Not Available
Quezon City, 1114
Philippines
Site Not Available
Chelyabinsk, 454 087
Russian Federation
Site Not Available
Ivanovo, 153040
Russian Federation
Site Not Available
Kazan, 420111
Russian Federation
Site Not Available
Moscow, 117837
Russian Federation
Site Not Available
Novosibirsk, 630047
Russian Federation
Site Not Available
Obninsk, 249036
Russian Federation
Site Not Available
Ryazan, 390011
Russian Federation
Site Not Available
Samara, 443066
Russian Federation
Site Not Available
St Petersburg, 197758
Russian Federation
Site Not Available
UFA, 450054
Russian Federation
Site Not Available
Singapore, 169610
Singapore
Site Not Available
Córdoba, 14004
Spain
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Elche, 03203
Spain
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Girona, 17007
Spain
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La Coruna, 15006
Spain
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La Laguna, 38320
Spain
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Madrid, 28034
Spain
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Santander, 39008
Spain
Site Not Available
Sevilla, 41013
Spain
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Valencia, 46010
Spain
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Zaragoza, 50009
Spain
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Gaevle, 80187
Sweden
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Uppsala, 751 85
Sweden
Site Not Available
Örebro, 701 85
Sweden
Site Not Available
Tainan, 704
Taiwan
Site Not Available
Taoyuan, 333
Taiwan
Site Not Available
Cherkassy, 18009
Ukraine
Site Not Available
Dnipropetrovsk, 49102
Ukraine
Site Not Available
Kiev, 03115
Ukraine
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Lvov, 79031
Ukraine
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Odessa, 65055
Ukraine
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Zaporozhye, 69104
Ukraine
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Chelsmford, CM1 7ET
United Kingdom
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Cottingham, HU16 5JQ
United Kingdom
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Epping, CM16 6TN
United Kingdom
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Huddersfield, HD3 3EA
United Kingdom
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Nottingham, NG5 1PB
United Kingdom
Site Not Available
Sheffield, S1O 2SJ
United Kingdom
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Swansea, SA2 8QA
United Kingdom
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Fullerton, California 92835
United States
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Santa Barbara, California 93105
United States
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Iowa City, Iowa 52242
United States
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Sioux City, Iowa 51101
United States
Site Not Available
Wichita, Kansas 67214-3728
United States
Site Not Available
Montevideo, 11200
Uruguay
Site Not Available

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