3
Indication details
- Combined Agent(s)
- Capecitabine
- Control Arm
- Placebo + capecitabine
- FDA Therapeutic Indication
- First-line treatment of patients with metastatic breast cancer in whom treatment with other ChT options, including taxanes or anthracyclines, is not considered appropriate. Patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with bevacizumab–capecitabine
- Tumour Sub-type
- Breast Cancer
- Tumour Stage
- Metastatic
- Trial Name
- RIBBON-1
- NCT Number
- NCT00262067
- Trial Phase
- Phase III
Approval details
- FDA Approval
- Not FDA approved
- EMA Approval
- EMA(CHMP) April 2011 EC decision June 2011
Primary Outcome(s)
- Primary Outcome(s)
- PFS
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 5.7 months
- PFS Gain
- 2.9 months
- PFS HR
- 0.69 (0.56-0.84)
Adjustments
- QoL Comment
-
QoL was not a prespecified endpoint
Score (after adjustments)
- Preliminary non-curative score
-
3
- Non-curative score
-
3
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 363
- Scorecard version
- 1
- Issue date
- 01.12.2022
- Last update
- 14.08.2023
Legend
Information about symbols, abbrevations and color codes
Red = negative
Green = positive
Grey = neutral
?
Grey + ? = neutral with pending data
- DFS
- Disease-Free Survival
- DoR
- Duration of Response
- EFS
- Event-Free Survival
- HR
- Hazard Ratio
- NEB
- No evaluable benefit
- NI
- Non-inferiority Study
- ORR
- Overall Response Rate
- OS
- Overall Surival
- pCR
- Pathological Complete Response/Remission
- PFS
- Progression-Free Survival
- QoL
- Quality of Life
- RFS
- Relapse-Free Survival
- RR
- Response Rate
QoL adjustments
Other adjustments*
Serious and disabling adverse effects
Red = negative / deterioration
Green = positive / improvement
QoL adjustments
Red = negative / deterioration
Green = positive / improvement
Other adjustments*
Red = negative / deterioration
Green = positive / improvement
Serious and disabling adverse effects
Red = negative / deterioration
Green = positive / improvement
* Other adjustments include:
- Long-term plateau in the survival curve
- Long-term plateau in the PFS curve
- Early stopping or crossover
- Only improved PFS mature data shows no OS advantage and no improved Qol.