Trial Outcomes & Findings for Phase III Study of Vinflunine Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer (NCT NCT01953003)
NCT ID: NCT01953003
Last Updated: 2019-05-02
Results Overview
The primary endpoint for the trial is progression-free survival calculated from the date of randomisation until the date of progression or the date of death whatever the cause of death. Patient who does not progressed will be censored at the date of last tumour assessment or the date of last contact of a follow-up showing no progression.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
112 participants
Primary outcome timeframe
progression date will be assessed evey 6 weeks starting from the randomization date until first documented progression or date of death from any cause whichever came first assessed up to 3 years
Results posted on
2019-05-02
Participant Flow
Participant milestones
| Measure |
Arm A : iv Vinflunine Plus Capecitabine
Vinflunine dose 280 mg/m² on day 1 of each cycle every 3 weeks, Capecitabine 825 mg/m² twice daily orally for 14 consecutive days beginning on day 1 of each cycle followed by 1 week of rest.
vinflunine: intraveinous administration day 1 once every 3 weeks, 280 mg/m²
Capecitabine: Arm A : 1650 mg/m² Arm B : 2500 mg/m²
|
Arm B : Capecitabine
1250 mg/m² twice daily orally for 14 consecutive days beginning on day 1 of each cycle followed by 1 week of rest
Capecitabine: Arm A : 1650 mg/m² Arm B : 2500 mg/m²
|
|---|---|---|
|
Overall Study
STARTED
|
56
|
56
|
|
Overall Study
COMPLETED
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
56
|
55
|
Reasons for withdrawal
| Measure |
Arm A : iv Vinflunine Plus Capecitabine
Vinflunine dose 280 mg/m² on day 1 of each cycle every 3 weeks, Capecitabine 825 mg/m² twice daily orally for 14 consecutive days beginning on day 1 of each cycle followed by 1 week of rest.
vinflunine: intraveinous administration day 1 once every 3 weeks, 280 mg/m²
Capecitabine: Arm A : 1650 mg/m² Arm B : 2500 mg/m²
|
Arm B : Capecitabine
1250 mg/m² twice daily orally for 14 consecutive days beginning on day 1 of each cycle followed by 1 week of rest
Capecitabine: Arm A : 1650 mg/m² Arm B : 2500 mg/m²
|
|---|---|---|
|
Overall Study
Not treated
|
0
|
1
|
|
Overall Study
Progressive disease
|
35
|
45
|
|
Overall Study
Related Adverse events
|
7
|
2
|
|
Overall Study
Non-related adverse events
|
0
|
2
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
14
|
4
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Arm A : iv Vinflunine Plus Capecitabine
n=56 Participants
Vinflunine dose 280 mg/m² on day 1 of each cycle every 3 weeks, Capecitabine 825 mg/m² twice daily orally for 14 consecutive days beginning on day 1 of each cycle followed by 1 week of rest.
vinflunine: intraveinous administration day 1 once every 3 weeks, 280 mg/m²
Capecitabine: Arm A : 1650 mg/m² Arm B : 2500 mg/m²
|
Arm B : Capecitabine
n=56 Participants
1250 mg/m² twice daily orally for 14 consecutive days beginning on day 1 of each cycle followed by 1 week of rest
Capecitabine: Arm A : 1650 mg/m² Arm B : 2500 mg/m²
|
Total
n=112 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=56 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=112 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
55 Participants
n=56 Participants
|
54 Participants
n=56 Participants
|
109 Participants
n=112 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=56 Participants
|
2 Participants
n=56 Participants
|
3 Participants
n=112 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=56 Participants
|
56 Participants
n=56 Participants
|
112 Participants
n=112 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=56 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=112 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Singapore
|
4 participants
n=56 Participants
|
5 participants
n=56 Participants
|
9 participants
n=112 Participants
|
|
Region of Enrollment
China
|
49 participants
n=56 Participants
|
46 participants
n=56 Participants
|
95 participants
n=112 Participants
|
|
Region of Enrollment
Taiwan
|
3 participants
n=56 Participants
|
5 participants
n=56 Participants
|
8 participants
n=112 Participants
|
|
Menopausal status
Menopausal
|
31 Participants
n=56 Participants
|
29 Participants
n=56 Participants
|
60 Participants
n=112 Participants
|
|
Menopausal status
Non-Menopausal
|
25 Participants
n=56 Participants
|
27 Participants
n=56 Participants
|
52 Participants
n=112 Participants
|
|
Tumour site - primary cancer
Right Breast
|
23 Participants
n=56 Participants
|
32 Participants
n=56 Participants
|
55 Participants
n=112 Participants
|
|
Tumour site - primary cancer
Left Breast
|
33 Participants
n=56 Participants
|
24 Participants
n=56 Participants
|
57 Participants
n=112 Participants
|
PRIMARY outcome
Timeframe: progression date will be assessed evey 6 weeks starting from the randomization date until first documented progression or date of death from any cause whichever came first assessed up to 3 yearsPopulation: The ITT population, comprised of all randomised patients
The primary endpoint for the trial is progression-free survival calculated from the date of randomisation until the date of progression or the date of death whatever the cause of death. Patient who does not progressed will be censored at the date of last tumour assessment or the date of last contact of a follow-up showing no progression.
Outcome measures
| Measure |
Arm A : iv Vinflunine Plus Capecitabine
n=56 Participants
Vinflunine dose 280 mg/m² on day 1 of each cycle every 3 weeks, Capecitabine 825 mg/m² twice daily orally for 14 consecutive days beginning on day 1 of each cycle followed by 1 week of rest.
vinflunine: intraveinous administration day 1 once every 3 weeks, 280 mg/m²
Capecitabine: Arm A : 1650 mg/m² Arm B : 2500 mg/m²
|
Arm B : Capecitabine
n=56 Participants
1250 mg/m² twice daily orally for 14 consecutive days beginning on day 1 of each cycle followed by 1 week of rest
Capecitabine: Arm A : 1650 mg/m² Arm B : 2500 mg/m²
|
|---|---|---|
|
Progression Free Survival (PFS)
Number of events (Participants)
|
42 Participants
|
46 Participants
|
|
Progression Free Survival (PFS)
Number of censored observations (Participants)
|
14 Participants
|
10 Participants
|
Adverse Events
Arm A : iv Vinflunine Plus Capecitabine
Serious events: 15 serious events
Other events: 54 other events
Deaths: 26 deaths
Arm B : Capecitabine
Serious events: 7 serious events
Other events: 46 other events
Deaths: 32 deaths
Serious adverse events
| Measure |
Arm A : iv Vinflunine Plus Capecitabine
n=56 participants at risk
Vinflunine dose 280 mg/m² on day 1 of each cycle every 3 weeks, Capecitabine 825 mg/m² twice daily orally for 14 consecutive days beginning on day 1 of each cycle followed by 1 week of rest.
vinflunine: intraveinous administration day 1 once every 3 weeks, 280 mg/m²
Capecitabine: Arm A : 1650 mg/m² Arm B : 2500 mg/m²
|
Arm B : Capecitabine
n=55 participants at risk
1250 mg/m² twice daily orally for 14 consecutive days beginning on day 1 of each cycle followed by 1 week of rest
Capecitabine: Arm A : 1650 mg/m² Arm B : 2500 mg/m²
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
3.6%
2/56 • 3 years 3 months
|
0.00%
0/55 • 3 years 3 months
|
|
Gastrointestinal disorders
Ileus
|
3.6%
2/56 • 3 years 3 months
|
0.00%
0/55 • 3 years 3 months
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.8%
1/56 • 3 years 3 months
|
0.00%
0/55 • 3 years 3 months
|
|
Gastrointestinal disorders
Mouth ulceration
|
1.8%
1/56 • 3 years 3 months
|
0.00%
0/55 • 3 years 3 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.6%
2/56 • 3 years 3 months
|
0.00%
0/55 • 3 years 3 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.8%
1/56 • 3 years 3 months
|
0.00%
0/55 • 3 years 3 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.8%
1/56 • 3 years 3 months
|
0.00%
0/55 • 3 years 3 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.8%
1/56 • 3 years 3 months
|
0.00%
0/55 • 3 years 3 months
|
|
General disorders
Fatigue
|
1.8%
1/56 • 3 years 3 months
|
0.00%
0/55 • 3 years 3 months
|
|
General disorders
Pain
|
1.8%
1/56 • 3 years 3 months
|
0.00%
0/55 • 3 years 3 months
|
|
Investigations
ALAT increased
|
0.00%
0/56 • 3 years 3 months
|
1.8%
1/55 • 3 years 3 months
|
|
Investigations
ASAT increased
|
0.00%
0/56 • 3 years 3 months
|
1.8%
1/55 • 3 years 3 months
|
|
Investigations
Neutrophil count decreased
|
1.8%
1/56 • 3 years 3 months
|
0.00%
0/55 • 3 years 3 months
|
|
Investigations
Platelet count decreased
|
1.8%
1/56 • 3 years 3 months
|
0.00%
0/55 • 3 years 3 months
|
|
Infections and infestations
Pneumonia
|
1.8%
1/56 • 3 years 3 months
|
0.00%
0/55 • 3 years 3 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.8%
1/56 • 3 years 3 months
|
0.00%
0/55 • 3 years 3 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.8%
1/56 • 3 years 3 months
|
0.00%
0/55 • 3 years 3 months
|
|
Renal and urinary disorders
Haematuria
|
1.8%
1/56 • 3 years 3 months
|
0.00%
0/55 • 3 years 3 months
|
|
General disorders
Chest discomfort
|
0.00%
0/56 • 3 years 3 months
|
1.8%
1/55 • 3 years 3 months
|
|
General disorders
Death
|
1.8%
1/56 • 3 years 3 months
|
0.00%
0/55 • 3 years 3 months
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/56 • 3 years 3 months
|
1.8%
1/55 • 3 years 3 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/56 • 3 years 3 months
|
1.8%
1/55 • 3 years 3 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/56 • 3 years 3 months
|
1.8%
1/55 • 3 years 3 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/56 • 3 years 3 months
|
1.8%
1/55 • 3 years 3 months
|
Other adverse events
| Measure |
Arm A : iv Vinflunine Plus Capecitabine
n=56 participants at risk
Vinflunine dose 280 mg/m² on day 1 of each cycle every 3 weeks, Capecitabine 825 mg/m² twice daily orally for 14 consecutive days beginning on day 1 of each cycle followed by 1 week of rest.
vinflunine: intraveinous administration day 1 once every 3 weeks, 280 mg/m²
Capecitabine: Arm A : 1650 mg/m² Arm B : 2500 mg/m²
|
Arm B : Capecitabine
n=55 participants at risk
1250 mg/m² twice daily orally for 14 consecutive days beginning on day 1 of each cycle followed by 1 week of rest
Capecitabine: Arm A : 1650 mg/m² Arm B : 2500 mg/m²
|
|---|---|---|
|
Investigations
Weight decreased
|
25.0%
14/56 • 3 years 3 months
|
16.4%
9/55 • 3 years 3 months
|
|
Investigations
Weight increased
|
7.1%
4/56 • 3 years 3 months
|
23.6%
13/55 • 3 years 3 months
|
|
Investigations
Neutrophil count decreased
|
10.7%
6/56 • 3 years 3 months
|
0.00%
0/55 • 3 years 3 months
|
|
Investigations
White blodd cell count decreased
|
5.4%
3/56 • 3 years 3 months
|
1.8%
1/55 • 3 years 3 months
|
|
General disorders
Fatigue
|
25.0%
14/56 • 3 years 3 months
|
16.4%
9/55 • 3 years 3 months
|
|
General disorders
Pain
|
17.9%
10/56 • 3 years 3 months
|
1.8%
1/55 • 3 years 3 months
|
|
General disorders
Oedema pheripheral
|
1.8%
1/56 • 3 years 3 months
|
9.1%
5/55 • 3 years 3 months
|
|
Blood and lymphatic system disorders
Neuropenia
|
19.6%
11/56 • 3 years 3 months
|
7.3%
4/55 • 3 years 3 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
12.5%
7/56 • 3 years 3 months
|
0.00%
0/55 • 3 years 3 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.4%
3/56 • 3 years 3 months
|
1.8%
1/55 • 3 years 3 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.4%
3/56 • 3 years 3 months
|
1.8%
1/55 • 3 years 3 months
|
|
Nervous system disorders
Headache
|
7.1%
4/56 • 3 years 3 months
|
5.5%
3/55 • 3 years 3 months
|
|
Nervous system disorders
Dizziness
|
7.1%
4/56 • 3 years 3 months
|
1.8%
1/55 • 3 years 3 months
|
|
Nervous system disorders
Hypoaesthenia
|
1.8%
1/56 • 3 years 3 months
|
7.3%
4/55 • 3 years 3 months
|
|
Skin and subcutaneous tissue disorders
Palmer-plantar erythrodysaesthesia
|
8.9%
5/56 • 3 years 3 months
|
30.9%
17/55 • 3 years 3 months
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
1.8%
1/56 • 3 years 3 months
|
7.3%
4/55 • 3 years 3 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.1%
9/56 • 3 years 3 months
|
5.5%
3/55 • 3 years 3 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.4%
3/56 • 3 years 3 months
|
3.6%
2/55 • 3 years 3 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.4%
3/56 • 3 years 3 months
|
0.00%
0/55 • 3 years 3 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/56 • 3 years 3 months
|
5.5%
3/55 • 3 years 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.7%
6/56 • 3 years 3 months
|
7.3%
4/55 • 3 years 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.8%
1/56 • 3 years 3 months
|
7.3%
4/55 • 3 years 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Oesopharyngeal pain
|
5.4%
3/56 • 3 years 3 months
|
0.00%
0/55 • 3 years 3 months
|
|
Hepatobiliary disorders
Liver disorder
|
1.8%
1/56 • 3 years 3 months
|
5.5%
3/55 • 3 years 3 months
|
|
Gastrointestinal disorders
Nausea
|
23.2%
13/56 • 3 years 3 months
|
21.8%
12/55 • 3 years 3 months
|
|
Gastrointestinal disorders
Constipation
|
33.9%
19/56 • 3 years 3 months
|
5.5%
3/55 • 3 years 3 months
|
|
Gastrointestinal disorders
Abdominal pain
|
23.2%
13/56 • 3 years 3 months
|
5.5%
3/55 • 3 years 3 months
|
|
Gastrointestinal disorders
Vomiting
|
19.6%
11/56 • 3 years 3 months
|
7.3%
4/55 • 3 years 3 months
|
|
Gastrointestinal disorders
Stomatitis
|
17.9%
10/56 • 3 years 3 months
|
5.5%
3/55 • 3 years 3 months
|
|
Gastrointestinal disorders
Diarrhoea
|
5.4%
3/56 • 3 years 3 months
|
12.7%
7/55 • 3 years 3 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
14.3%
8/56 • 3 years 3 months
|
1.8%
1/55 • 3 years 3 months
|
|
Gastrointestinal disorders
Abdominal distension
|
12.5%
7/56 • 3 years 3 months
|
0.00%
0/55 • 3 years 3 months
|
|
Gastrointestinal disorders
Mouth ulceration
|
5.4%
3/56 • 3 years 3 months
|
3.6%
2/55 • 3 years 3 months
|
|
Gastrointestinal disorders
Gastroesophagal reflux disease
|
5.4%
3/56 • 3 years 3 months
|
5.5%
3/55 • 3 years 3 months
|
|
Gastrointestinal disorders
Oral pain
|
5.4%
3/56 • 3 years 3 months
|
0.00%
0/55 • 3 years 3 months
|
Additional Information
Karim Keddad, Head of Medical Unit
Institut de Recherche Pierre Fabre, Toulouse France
Phone: +33.5.34.50.61.69
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place