Trial of Vinflunine Plus Capecitabine in Advanced Breast Cancer

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ClinicalTrials.gov Identifier: NCT01095003

Recruitment Status : Completed

First Posted : March 29, 2010

Results First Posted : September 13, 2019

Last Update Posted : April 28, 2022

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Sponsor:

Information provided by (Responsible Party):

Pierre Fabre Medicament

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Breast Cancer
Interventions	Drug: Vinflunine plus Capecitabine Drug: Capecitabine
Enrollment	770

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Vinflunine Plus Capecitabine	Capecitabine Single-agent
Arm/Group Description	Vinflunine plus Capecitabine: Vinfl...	Capecitabine: Capecitabine 825mg/m²...
Arm/Group Description	Vinflunine plus Capecitabine: Vinflunine 280mg/m² as a 20-minute i.v. infusion on day 1 of each cycle repeated every 3 weeks Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks	Capecitabine: Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks
Period Title: Overall Study
Started	384	386
Completed	0	0
Not Completed	384	386

Baseline Characteristics

Arm/Group Title		Capecitabine Single-agent	Vinflunine Plus Capecitabine	Total
Arm/Group Description		Capecitabine 825mg/m² per os twice ...	Vinflunine plus Capecitabine: Vinfl...	Total of all reporting groups
Arm/Group Description		Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks	Vinflunine plus Capecitabine: Vinflunine 280mg/m² as a 20-minute i.v. infusion on day 1 of each cycle repeated every 3 weeks Capecitabine: Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks	Total of all reporting groups
Overall Number of Baseline Participants		386	384	770
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	386 participants	384 participants	770 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	340 88.1%	329 85.7%	669 86.9%
	>=65 years	46 11.9%	55 14.3%	101 13.1%
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	386 participants	384 participants	770 participants
	Female	386 100.0%	384 100.0%	770 100.0%
	Male	0 0.0%	0 0.0%	0 0.0%

Outcome Measures

1.Primary Outcome


Title	Progression Free Survival
Description	PFS is defined as time from date of randomization to date of the first...
Description	PFS is defined as time from date of randomization to date of the first documentation of objective tumor progression (according to the Independent Response Review Committee (IRC) and based on RECIST version 1.1) or death due to any cause. The PFS was primarily analysed in the Intent-to-treat (ITT) population. Patients lost to follow-up, or without a known record of progression or death at time of analysis had the progression-free survival censored at the date of last tumour assessment or the date of last contact of a follow-up showing no progression, whichever occurs last.
Time Frame	Baseline up to 2 years 7 months

Outcome Measure Data

Analysis Population Description

ITT population


Arm/Group Title	Vinflunine Plus Capecitabine	Capecitabine Single-agent
Arm/Group Description:	Vinflunine plus Capecitabine: Vinfl...	Capecitabine: Capecitabine 825mg/m²...
Arm/Group Description:	Vinflunine plus Capecitabine: Vinflunine 280mg/m² as a 20-minute i.v. infusion on day 1 of each cycle repeated every 3 weeks Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks	Capecitabine: Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks
Overall Number of Participants Analyzed	384	386
Median (95% Confidence Interval) Unit of Measure: Months
	5.6 (5.3 to 6.3)	4.3 (4.1 to 5.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vinflunine Plus Capecitabine, Capecitabine Single-agent
	Comments	The final analysis of progression free survival was conducted once the required number of events(615 progressions or deaths) was reached.using the IRC assessment of date of progressions following the blinded radiological and clinical review of data. Kaplan-Meier curves and life tables by treatment arm were provided.A stratified Cox proportional model was used to compare the two treatment arms
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0426
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.84
	Confidence Interval	(2-Sided) 95% 0.71 to 0.99
	Estimation Comments	[Not Specified]

2.Secondary Outcome


Title	Overall Survival
Description	The overall survival (OS) was defined as the duration between the date...
Description	The overall survival (OS) was defined as the duration between the date of randomisation and the date of death from any cause. The OS analysis was performed in the ITT population and the eligible and per protocol populations once the required number of events (631 deaths) was observed Patients lost to follow-up, or without a known record of death at time of analysis had the OS censored at the date of last contact.
Time Frame	Baseline upto 3 years 10 months

Outcome Measure Data

Analysis Population Description

ITT population


Arm/Group Title	Vinflunine Plus Capecitabine	Capecitabine Single-agent
Arm/Group Description:	Vinflunine plus Capecitabine: Vinfl...	Capecitabine: Capecitabine 825mg/m²...
Arm/Group Description:	Vinflunine plus Capecitabine: Vinflunine 280mg/m² as a 20-minute i.v. infusion on day 1 of each cycle repeated every 3 weeks Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks	Capecitabine: Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks
Overall Number of Participants Analyzed	384	386
Median (95% Confidence Interval) Unit of Measure: Months
	13.9 (11.9 to 15)	11.7 (10.8 to 13.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vinflunine Plus Capecitabine, Capecitabine Single-agent
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.7657
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.98
	Confidence Interval	(2-Sided) 95% 0.83 to 1.15
	Estimation Comments	[Not Specified]

3.Secondary Outcome


Title	Overall Response Rate (ORR)
Description	ORR defined as documentation of complete or partial response that was ...
Description	ORR defined as documentation of complete or partial response that was subsequently confirmed to first documentation of disease progression or to death due to any cause, whichever occurred first.
Time Frame	Baseline upto 2 years 7 months

Outcome Measure Data

Analysis Population Description

ITT population


Arm/Group Title	Vinflunine Plus Capecitabine	Capecitabine Single-agent
Arm/Group Description:	Vinflunine plus Capecitabine: Vinfl...	Capecitabine: Capecitabine 825mg/m²...
Arm/Group Description:	Vinflunine plus Capecitabine: Vinflunine 280mg/m² as a 20-minute i.v. infusion on day 1 of each cycle repeated every 3 weeks Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks	Capecitabine: Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks
Overall Number of Participants Analyzed	384	386
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: Percent
	22.9 (18.8 to 27.5)	17.9 (14.2 to 22.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vinflunine Plus Capecitabine, Capecitabine Single-agent
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.103
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

4.Secondary Outcome


Title	Disease Control Rate
Description	Disease control rate defined (DCR) as the sum of confirmed complete re...
Description	Disease control rate defined (DCR) as the sum of confirmed complete response, confirmed partial response and stabilisation rate.
Time Frame	Baseline up to 2 years 7 months

Outcome Measure Data

Analysis Population Description

ITT population


Arm/Group Title	Vinflunine Plus Capecitabine	Capecitabine Single-agent
Arm/Group Description:	Vinflunine plus Capecitabine: Vinfl...	Capecitabine: Capecitabine 825mg/m²...
Arm/Group Description:	Vinflunine plus Capecitabine: Vinflunine 280mg/m² as a 20-minute i.v. infusion on day 1 of each cycle repeated every 3 weeks Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks	Capecitabine: Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks
Overall Number of Participants Analyzed	384	386
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: Percent
	57.3 (52.2 to 62.3)	47.9 (42.9 to 53)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vinflunine Plus Capecitabine, Capecitabine Single-agent
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0089
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

5.Secondary Outcome


Title	Duration of Response
Description	Measured from the first time that measurement criteria were first met ...
Description	Measured from the first time that measurement criteria were first met for objective response (documented CR or PR) until recurrence/progression or death whatever the cause.
Time Frame	Baseline up to 2 years 7 months

Outcome Measure Data

Analysis Population Description

ITT


Arm/Group Title	Vinflunine Plus Capecitabine	Capecitabine Single-agent
Arm/Group Description:	Patients received (in combination w...	Capecitabine at the dose of 825mg/m...
Arm/Group Description:	Patients received (in combination with capecitabine) • Vinflunine at the dose of 280 mg/m² and as a 20-minute IV. infusion on day 1 of each cycle repeated every 3 weeks. Vinflunine plus Capecitabine: Vinflunine 280mg/m² as a 20-minute i.v. infusion on day 1 of each cycle repeated every 3 weeks Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks	Capecitabine at the dose of 825mg/m² per os twice per day each morning and each evening for 14 consecutive days beginning on day 1 of each cycle repeated every 3 weeks (self-administered). Capecitabine: Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks
Overall Number of Participants Analyzed	384	386
Median (Full Range) Unit of Measure: Months
	57.3 (52.2 to 62.3)	47.9 (42.9 to 53)

Adverse Events

Time Frame	Adverse events (AEs) are reported from time of first dose of study treatment up to the end of study period (treatment period + follow-up period) up to 5 years 9 months.
Adverse Event Reporting Description	AEs were collected from treated patients who received at least one dose of study treatment (383 patients in each arm). The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another. Specific AE tables were generated separately as per European format.

Arm/Group Title	Vinflunine Plus Capecitabine	Capecitabine Single-agent
Arm/Group Description	Vinflunine plus Capecitabine: Vinfl...	Capecitabine: Capecitabine 825mg/m²...
Arm/Group Description	Vinflunine plus Capecitabine: Vinflunine 280mg/m² as a 20-minute i.v. infusion on day 1 of each cycle repeated every 3 weeks Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks	Capecitabine: Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks
All-Cause Mortality
	Vinflunine Plus Capecitabine	Capecitabine Single-agent
	Affected / at Risk (%)	Affected / at Risk (%)
Total	345/384 (89.84%)	348/386 (90.16%)
Serious Adverse Events Serious Adverse Events
	Vinflunine Plus Capecitabine	Capecitabine Single-agent
	Affected / at Risk (%)	Affected / at Risk (%)
Total	107/383 (27.94%)	85/383 (22.19%)
Blood and lymphatic system disorders
Anaemia ^† 1	4/383 (1.04%)	3/383 (0.78%)
Febrile neutropenia ^† 1	7/383 (1.83%)	2/383 (0.52%)
Haemoytique anaemia ^† 1	0/383 (0.00%)	0/383 (0.00%)
Leukopenia ^† 1	1/383 (0.26%)	0/383 (0.00%)
Neutropenia ^† 1	6/383 (1.57%)	1/383 (0.26%)
Thrombocytopenia ^† 1	2/383 (0.52%)	1/383 (0.26%)
Cardiac disorders
Anginal pectoris ^† 1	1/383 (0.26%)	0/383 (0.00%)
Cardiomyopathy ^† 1	0/383 (0.00%)	1/383 (0.26%)
Ear and labyrinth disorders
Ear pain ^† 1	0/383 (0.00%)	1/383 (0.26%)
Gastrointestinal disorders
Abdominal distension ^† 1	1/383 (0.26%)	0/383 (0.00%)
Abdominal pain ^† 1	6/383 (1.57%)	3/383 (0.78%)
Abdominal pain upper ^† 1	4/383 (1.04%)	0/383 (0.00%)
Colitis ^† 1	0/383 (0.00%)	1/383 (0.26%)
Constipation ^† 1	9/383 (2.35%)	0/383 (0.00%)
Diarrhoea ^† 1	4/383 (1.04%)	6/383 (1.57%)
Gastritis ^† 1	1/383 (0.26%)	0/383 (0.00%)
Ileus paralytic ^† 1	1/383 (0.26%)	0/383 (0.00%)
Intestinal obstruction ^† 1	6/383 (1.57%)	1/383 (0.26%)
Nausea ^† 1	3/383 (0.78%)	1/383 (0.26%)
Reflux gastric ^† 1	0/383 (0.00%)	1/383 (0.26%)
Stomatitis ^† 1	4/383 (1.04%)	1/383 (0.26%)
Subileus ^† 1	1/383 (0.26%)	0/383 (0.00%)
Vomiting ^† 1	6/383 (1.57%)	0/383 (0.00%)
General disorders
Asthenia ^† 1	1/383 (0.26%)	0/383 (0.00%)
Chest pain ^† 1	3/383 (0.78%)	0/383 (0.00%)
Condition aggravated ^† 1	2/383 (0.52%)	6/383 (1.57%)
Death ^† 1	0/383 (0.00%)	2/383 (0.52%)
Fatigue ^† 1	2/383 (0.52%)	1/383 (0.26%)
Injection site extravasation ^† 1	1/383 (0.26%)	0/383 (0.00%)
Mucosal inflammation ^† 1	1/383 (0.26%)	0/383 (0.00%)
Multi organ failure ^† 1	0/383 (0.00%)	1/383 (0.26%)
Pain ^† 1	1/383 (0.26%)	0/383 (0.00%)
Pyrexia ^† 1	1/383 (0.26%)	1/383 (0.26%)
Sudden death ^† 1	1/383 (0.26%)	2/383 (0.52%)
Hepatobiliary disorders
Cholecytitis ^† 1	1/383 (0.26%)	0/383 (0.00%)
Cholecystetis acute ^† 1	0/383 (0.00%)	1/383 (0.26%)
Hepatic pain ^† 1	1/383 (0.26%)	0/383 (0.00%)
Hyperbilirubinemai ^† 1	1/383 (0.26%)	3/383 (0.78%)
Immune system disorders
Hypersensitivity ^† 1	0/383 (0.00%)	1/383 (0.26%)
Infections and infestations
Cellulitis ^† 1	1/383 (0.26%)	0/383 (0.00%)
Gastroenteritis ^† 1	0/383 (0.00%)	1/383 (0.26%)
Herpes Zoster ^† 1	1/383 (0.26%)	0/383 (0.00%)
Localised infection ^† 1	1/383 (0.26%)	0/383 (0.00%)
Lower respiaratory tract infection ^† 1	1/383 (0.26%)	0/383 (0.00%)
Neutropenic infection ^† 1	1/383 (0.26%)	0/383 (0.00%)
Neutropenic sepsis ^† 1	1/383 (0.26%)	0/383 (0.00%)
Pneumonia ^† 1	3/383 (0.78%)	2/383 (0.52%)
Pneumonia streptococcal ^† 1	1/383 (0.26%)	0/383 (0.00%)
Respiratory tract infection ^† 1	0/383 (0.00%)	1/383 (0.26%)
Sepsis ^† 1	1/383 (0.26%)	0/383 (0.00%)
Urinary tract infection ^† 1	1/383 (0.26%)	0/383 (0.00%)
Injury, poisoning and procedural complications
Device occlusion ^† 1	1/383 (0.26%)	0/383 (0.00%)
Femur fracture ^† 1	1/383 (0.26%)	1/383 (0.26%)
Medication error ^† 1	1/383 (0.26%)	0/383 (0.00%)
Pneumothorax traumatic ^† 1	1/383 (0.26%)	0/383 (0.00%)
Wrist fracture ^† 1	1/383 (0.26%)	0/383 (0.00%)
Investigations
ALAT increased ^† 1	0/383 (0.00%)	1/383 (0.26%)
ASTT increased ^† 1	0/383 (0.00%)	1/383 (0.26%)
Biopsy ^† 1	1/383 (0.26%)	0/383 (0.00%)
Metabolism and nutrition disorders
Anorexia ^† 1	1/383 (0.26%)	1/383 (0.26%)
Dehydration ^† 1	2/383 (0.52%)	1/383 (0.26%)
Diabetes mellitus inadequate control ^† 1	0/383 (0.00%)	1/383 (0.26%)
Hyperglycaemia ^† 1	1/383 (0.26%)	0/383 (0.00%)
Hypoalbuminaemia ^† 1	0/383 (0.00%)	1/383 (0.26%)
Hypokaelemia ^† 1	1/383 (0.26%)	0/383 (0.00%)
Hyponatraemia ^† 1	2/383 (0.52%)	0/383 (0.00%)
Musculoskeletal and connective tissue disorders
Bone pain ^† 1	0/383 (0.00%)	2/383 (0.52%)
Musculoskeletal chest pain ^† 1	0/383 (0.00%)	1/383 (0.26%)
Myalgia ^† 1	1/383 (0.26%)	0/383 (0.00%)
Pain in extremity ^† 1	1/383 (0.26%)	0/383 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain ^† 1	1/383 (0.26%)	0/383 (0.00%)
Colon cancer ^† 1	0/383 (0.00%)	1/383 (0.26%)
Malignant neoplasmprogression ^† 1	34/383 (8.88%)	32/383 (8.36%)
Malignant pleural effusion ^† 1	2/383 (0.52%)	0/383 (0.00%)
Paraneoplastic syndrome ^† 1	1/383 (0.26%)	0/383 (0.00%)
Nervous system disorders
Brachial plexopathy ^† 1	1/383 (0.26%)	0/383 (0.00%)
Cerebrovascular accident ^† 1	2/383 (0.52%)	2/383 (0.52%)
Coma ^† 1	0/383 (0.00%)	1/383 (0.26%)
Headache ^† 1	1/383 (0.26%)	1/383 (0.26%)
Hydrocephalus ^† 1	0/383 (0.00%)	1/383 (0.26%)
Intracranial pressure increased ^† 1	1/383 (0.26%)	0/383 (0.00%)
Subarachnoid haemorrrhage ^† 1	0/383 (0.00%)	1/383 (0.26%)
Vascular encephalopathy ^† 1	0/383 (0.00%)	1/383 (0.26%)
Psychiatric disorders
Anxiety ^† 1	1/383 (0.26%)	0/383 (0.00%)
Reproductive system and breast disorders
Dysfunctional uterine bleeding ^† 1	0/383 (0.00%)	1/383 (0.26%)
Respiratory, thoracic and mediastinal disorders
Bronchospasm ^† 1	0/383 (0.00%)	1/383 (0.26%)
Dyspnoea ^† 1	1/383 (0.26%)	5/383 (1.31%)
Hydrothorax ^† 1	0/383 (0.00%)	1/383 (0.26%)
Pleuritic pain ^† 1	1/383 (0.26%)	0/383 (0.00%)
Pneumothorax ^† 1	1/383 (0.26%)	0/383 (0.00%)
Pulmonary Embolism ^† 1	2/383 (0.52%)	3/383 (0.78%)
PPES ^† 1	0/383 (0.00%)	1/383 (0.26%)
Surgical and medical procedures
Anal fistula excision ^† 1	0/383 (0.00%)	1/383 (0.26%)
Bile duct stent insertion ^† 1	0/383 (0.00%)	1/383 (0.26%)
Central venous catherisation ^† 1	2/383 (0.52%)	0/383 (0.00%)
Haemorrhoid operation ^† 1	0/383 (0.00%)	1/383 (0.26%)
Surgery ^† 1	1/383 (0.26%)	0/383 (0.00%)
Vascular disorders
Deep vein thrombosis ^† 1	2/383 (0.52%)	1/383 (0.26%)
Hypertensive crisis ^† 1	1/383 (0.26%)	1/383 (0.26%)
Lymphoedema ^† 1	1/383 (0.26%)	0/383 (0.00%)
Thrombophlebitis ^† 1	1/383 (0.26%)	0/383 (0.00%)
1 Term from vocabulary, MedDRA (12.0) † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Vinflunine Plus Capecitabine	Capecitabine Single-agent
	Affected / at Risk (%)	Affected / at Risk (%)
Total	257/383 (67.10%)	262/383 (68.41%)
Blood and lymphatic system disorders
Neutropenia ^† 1	73/383 (19.06%)	32/383 (8.36%)
Cardiac disorders
Cardiac disorders ^† 1	28/383 (7.31%)	22/383 (5.74%)
Eye disorders
Eye disorders ^† 1	23/383 (6.01%)	31/383 (8.09%)
Gastrointestinal disorders
Abdominal pain ^† 1	119/383 (31.07%)	78/383 (20.37%)
Abdominal pain upper ^† 1	49/383 (12.79%)	21/383 (5.48%)
Constipation ^† 1	108/383 (28.20%)	30/383 (7.83%)
Diarrhoea ^† 1	86/383 (22.45%)	116/383 (30.29%)
Nausea ^† 1	123/383 (32.11%)	97/383 (25.33%)
Stomatitis ^† 1	88/383 (22.98%)	41/383 (10.70%)
Vomiting ^† 1	106/383 (27.68%)	62/383 (16.19%)
General disorders
Asthenia ^† 1	66/383 (17.23%)	39/383 (10.18%)
Fatigue ^† 1	111/383 (28.98%)	92/383 (24.02%)
Injection site reaction ^† 1	63/383 (16.45%)	0/383 (0.00%)
Oedema peripheral ^† 1	21/383 (5.48%)	22/383 (5.74%)
Pyrexia ^† 1	46/383 (12.01%)	35/383 (9.14%)
Hepatobiliary disorders
Hepatobiliary disorders ^† 1	29/383 (7.57%)	20/383 (5.22%)
Infections and infestations
Infections and infestations ^† 1	95/383 (24.80%)	90/383 (23.50%)
Investigations
Weight decreased ^† 1	113/383 (29.50%)	74/383 (19.32%)
Weight increased ^† 1	55/383 (14.36%)	48/383 (12.53%)
Metabolism and nutrition disorders
Anorexia ^† 1	63/383 (16.45%)	37/383 (9.66%)
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	48/383 (12.53%)	14/383 (3.66%)
Back pain ^† 1	21/383 (5.48%)	25/383 (6.53%)
Bone pain ^† 1	39/383 (10.18%)	30/383 (7.83%)
Musculoskeletal pain ^† 1	20/383 (5.22%)	11/383 (2.87%)
Myalgia ^† 1	36/383 (9.40%)	5/383 (1.31%)
Pain in extremity ^† 1	37/383 (9.66%)	23/383 (6.01%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression ^† 1	34/383 (8.88%)	33/383 (8.62%)
Nervous system disorders
Dizziness ^† 1	33/383 (8.62%)	23/383 (6.01%)
Headache ^† 1	59/383 (15.40%)	38/383 (9.92%)
Peripheral sensory neuropathy ^† 1	33/383 (8.62%)	19/383 (4.96%)
Psychiatric disorders
Insomnia ^† 1	26/383 (6.79%)	14/383 (3.66%)
Respiratory, thoracic and mediastinal disorders
Cough ^† 1	40/383 (10.44%)	34/383 (8.88%)
Dyspnoea ^† 1	52/383 (13.58%)	51/383 (13.32%)
Skin and subcutaneous tissue disorders
Alopecia ^† 1	42/383 (10.97%)	3/383 (0.78%)
PPES ^† 1	90/383 (23.50%)	180/383 (47.00%)
Vascular disorders
Vascular disorders ^† 1	61/383 (15.93%)	28/383 (7.31%)
1 Term from vocabulary, MedDRA (12.0) † Indicates events were collected by systematic assessment

Limitations and Caveats

No limitations and caveats

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Karim Keddad
Organization:	Institut de Recherche Pierre Fabre
Phone:	+33.5.34.50.61.69
EMail:	Karim.keddad@pierre-fabre.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Martin M, Campone M, Bondarenko I, Sakaeva D, Krishnamurthy S, Roman L, Lebedeva L, Vedovato JC, Aapro M. Randomised phase III trial of vinflunine plus capecitabine versus capecitabine alone in patients with advanced breast cancer previously treated with an anthracycline and resistant to taxane. Ann Oncol. 2018 May 1;29(5):1195-1202. doi: 10.1093/annonc/mdy063.

Layout table for additonal information

Responsible Party:	Pierre Fabre Medicament
ClinicalTrials.gov Identifier:	NCT01095003
Other Study ID Numbers:	L00070 IN 305 B0 2008-004171-21 ( EudraCT Number )
First Submitted:	March 24, 2010
First Posted:	March 29, 2010
Results First Submitted:	May 27, 2019
Results First Posted:	September 13, 2019
Last Update Posted:	April 28, 2022

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