XeNA Study - A Study of Xeloda (Capecitabine) in Patients With Invasive Breast Cancer

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00127933
• Collaborator: (none)
• Enrollment: 157
• Locations: 38
• Arms: 2
• Duration (Months): 47
• Patients Per Site: 4.1
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This single arm study stratified patients into two treatment cohorts based on HER2-neu overexpression/amplification. Each cohort will be independently powered for the primary endpoint. The study will evaluate the efficacy, safety and impact on quality of life of treatment with oral Xeloda plus intravenous (iv) Taxotere (docetaxel). Patients with HER2-neu negative breast cancer will receive chemotherapy alone with oral Xeloda plus intravenous (iv) Taxotere (docetaxel). Patients with HER2-neu positive breast cancer, will receive the same chemotherapy in combination with intravenous (iv) Herceptin (trastuzumab). Patients will receive 3-weekly cycles of treatment with Xeloda (825mg/m2 oral administration [po] twice daily (bid) on days 1-14) + Taxotere (75mg/m2 iv on day 1). HER2-neu positive patients will also receive Herceptin (loading dose of 4mg/kg iv followed by 2mg/kg iv weekly). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: capecitabine [Xeloda]; Drug: Taxotere; Drug: Herceptin (HER2-neu positive patients only); Drug: capecitabine [Xeloda]; Drug: Taxotere	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 157 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-label Study of Xeloda Plus Taxotere on Treatment Response in Patients With HER2-neu-negative, and the Addition of Herceptin for HER2-neu-positive Breast Cancer
• Study Start Date: Aug 1, 2005
• Actual Primary Completion Date: Apr 1, 2009
• Actual Study Completion Date: Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HER2-NEU Positive	Drug: capecitabine [Xeloda]; 825mg/m2 po bid on days 1-14 of each 3 week cycle; Drug: Taxotere; 75mg/m2 iv on day 1 of each 3 week cycle; Drug: Herceptin (HER2-neu positive patients only); 4mg/kg iv (loading dose) followed by 2mg/kg iv weekly
Experimental: HER2-NEU Negative	Drug: capecitabine [Xeloda]; 825mg/m2 po bid on days 1-14 of each 3 week cycle; Drug: Taxotere; 75mg/m2 iv on day 1 of each 3 week cycle

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Assessed for Pathological Complete Response (pCR) Plus Near Complete (npCR) in Primary Breast Tumor at Time of Definitive Surgery [at the time of definitive surgery; after four 3-week cycles (3-4 months)]

   Pathological complete response was defined as the absence of histological evidence of invasive breast cancer cells in the tissue specimen removed from the breast after 4 cycles of preoperative treatment. Near pCR (npCR) was defined as the presence of invasive tumor cells with a size of 5 mm or less in aggregate in the tissue specimen removed from the breast after 4 cycles of preoperative treatment. Only pathological assessments occurring prior to the first date of adjuvant treatment were included in the analysis of pCR rate.

Secondary Outcome Measures

1. Percentage of Participants With Complete Pathological Response in the Primary Breast Tumor at the Time of Definitive Surgery [at the time of definitive surgery; after four 3-week cycles (3-4 months)]

   Pathological complete response was defined as the absence of histological evidence of invasive breast cancer cells in the tissue specimen removed from the breast after 4 cycles of preoperative treatment.

2. Percentage of Participants With Overall Clinical Response (Complete Response (CR) Plus Partial Response (PR)) [post 2 and 4, 3-week cycles of treatment]

   The best overall response in an individual patient, according to RECIST, during preoperative treatment was the best response recorded from the start of study treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the baseline assessment) or completion of preoperative treatment. Patients with CR or PR were considered responders. Patients with no tumor assessment after the start of study treatment were considered nonresponders.

3. Percentage of Participants With Local Recurrence [30 - 1102 days]

   Local recurrence was defined as evidence of recurrent carcinoma in the same breast where it was diagnosed initially before preoperative treatment.

4. Participants With Disease-Free Survival [30 - 1102 days]

   Disease-free survival was defined as the time from date of surgery to date of first evidence of cancer recurrence in the breast (ie, local or distant recurrence or contra lateral disease) or death from any cause, whichever came first. Patients who were alive or withdrawn from the study and had no evidence of disease recurrence and for whom there was CRF evidence that evaluations had been made were censored at the date of the last clinical follow-up assessment when the patient was known to be disease free.

5. Participants With Overall Survival [22 - 1191 days]

   Overall survival was defined as the time from date of start of study treatment to the date of death, regardless of the cause of death. Patients who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Patients without follow-up assessment were censored at the day of the last dose. Patients with no post-baseline information were censored at the start of study treatment.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• women >=18 years of age;

• newly diagnosed;

• infiltrating (invasive) HER2-neu-negative or HER2-neu-positive breast cancer.

Exclusion Criteria:

• evidence of metastatic disease, except ipsilateral (same side) axillary lymph nodes;

• previous systemic or local primary treatment.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Los Angeles	California	United States	90057
2		Montebello	California	United States	90640
3		Palm Springs	California	United States	92262
4		San Diego	California	United States	92123
5		Farmington	Connecticut	United States	06030
6		Melbourne	Florida	United States	32910
7		Miami	Florida	United States	33136
8		Tamarac	Florida	United States	33321
9		Savannah	Georgia	United States	31405
10		Indianapolis	Indiana	United States	46227
11		Indianapolis	Indiana	United States	46260
12		Iowa City	Iowa	United States	52242
13		Alexandria	Louisiana	United States	71301
14		Scarborough	Maine	United States	04074
15		Baltimore	Maryland	United States	21201
16		Edina	Minnesota	United States	55435
17		Jefferson City	Missouri	United States	65109
18		Rolla	Missouri	United States	65401
19		St Louis	Missouri	United States	63141
20		Neptune	New Jersey	United States	07754
21		Albuquerque	New Mexico	United States	87102
22		Albuquerque	New Mexico	United States	87108
23		Albuquerque	New Mexico	United States	87131-5636
24		Santa Fe	New Mexico	United States	87505
25		New York	New York	United States	10003
26		Charlotte	North Carolina	United States	28233-3549
27		Canton	Ohio	United States	44718
28		Pittsburgh	Pennsylvania	United States	15213
29		Pottsville	Pennsylvania	United States	17901
30		Charleston	South Carolina	United States	29425
31		Georgetown	South Carolina	United States	29442
32		Sumter	South Carolina	United States	29150
33		Memphis	Tennessee	United States	38104
34		Memphis	Tennessee	United States	38120
35		Dallas	Texas	United States	75231
36		Dallas	Texas	United States	75390-9034
37		Burlington	Vermont	United States	05401
38		Abingdon	Virginia	United States	24211

Sponsors and Collaborators

• Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Clinical Study Report Synopsis

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00127933
• Other Study ID Numbers: ML18530
• First Posted: Aug 9, 2005
• Last Update Posted: Aug 10, 2011
• Last Verified: Jul 1, 2011

• Additional relevant MeSH terms: Breast Neoplasms; Capecitabine; Docetaxel; Trastuzumab

Study Results

Participant Flow

Arm/Group Title	HER2-Neu Negative	HER2-Neu Positive
Arm/Group Description	Dose and route per treatment cycle (Q3W): Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 HER2-neu negative: capecitabine + docetaxel Duration: Four 3-week treatment cycles	Dose and route per treatment cycle (Q3W): Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly HER2-neu positive: capecitabine + docetaxel + trastuzumab Duration: Four 3-week treatment cycles
Period Title: Overall Study
STARTED	123	34
Pathological Response	101	28
Clinical Response	122	34
Safety Population	122	34
Quality of Life Population	118	33
Postoperative	98	27
COMPLETED	122	34
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	HER2-Neu Negative	HER2-Neu Positive	Total
Arm/Group Description	Dose and route per treatment cycle (Q3W): Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 HER2-neu negative: capecitabine + docetaxel Duration: Four 3-week treatment cycles	Dose and route per treatment cycle (Q3W): Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly HER2-neu positive: capecitabine + docetaxel + trastuzumab Duration: Four 3-week treatment cycles	Total of all reporting groups
Overall Participants	122	34	156
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51.0 (11.20)	52.2 (9.36)	51.3 (10.79)
Sex: Female, Male (Count of Participants)
Female	122 100%	34 100%	156 100%
Male	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Assessed for Pathological Complete Response (pCR) Plus Near Complete (npCR) in Primary Breast Tumor at Time of Definitive Surgery
Description	Pathological complete response was defined as the absence of histological evidence of invasive breast cancer cells in the tissue specimen removed from the breast after 4 cycles of preoperative treatment. Near pCR (npCR) was defined as the presence of invasive tumor cells with a size of 5 mm or less in aggregate in the tissue specimen removed from the breast after 4 cycles of preoperative treatment. Only pathological assessments occurring prior to the first date of adjuvant treatment were included in the analysis of pCR rate.
Time Frame	at the time of definitive surgery; after four 3-week cycles (3-4 months)

Outcome Measure Data

Analysis Population Description

Pathological Response Evaluable Population

Arm/Group Title	HER2-Neu Negative	HER2-Neu Positive
Arm/Group Description	Dose and route per treatment cycle (Q3W): Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 HER2-neu negative: capecitabine + docetaxel Duration: Four 3-week treatment cycles	Dose and route per treatment cycle (Q3W): Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly HER2-neu positive: capecitabine + docetaxel + trastuzumab Duration: Four 3-week treatment cycles
Measure Participants	101	28
Number (95% Confidence Interval) [percentage of participants]	15.8 13%	50.0 147.1%

2. Secondary Outcome

Title	Percentage of Participants With Complete Pathological Response in the Primary Breast Tumor at the Time of Definitive Surgery
Description	Pathological complete response was defined as the absence of histological evidence of invasive breast cancer cells in the tissue specimen removed from the breast after 4 cycles of preoperative treatment.
Time Frame	at the time of definitive surgery; after four 3-week cycles (3-4 months)

Outcome Measure Data

Analysis Population Description

Pathological Response Evaluable Population

Arm/Group Title	HER2-Neu Negative	HER2-Neu Positive
Arm/Group Description	Dose and route per treatment cycle (Q3W): Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 HER2-neu negative: capecitabine + docetaxel Duration: Four 3-week treatment cycles	Dose and route per treatment cycle (Q3W): Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly HER2-neu positive: capecitabine + docetaxel + trastuzumab Duration: Four 3-week treatment cycles
Measure Participants	101	28
Number (95% Confidence Interval) [percentage of participants]	9.9 8.1%	35.7 105%

3. Secondary Outcome

Title	Percentage of Participants With Overall Clinical Response (Complete Response (CR) Plus Partial Response (PR))
Description	The best overall response in an individual patient, according to RECIST, during preoperative treatment was the best response recorded from the start of study treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the baseline assessment) or completion of preoperative treatment. Patients with CR or PR were considered responders. Patients with no tumor assessment after the start of study treatment were considered nonresponders.
Time Frame	post 2 and 4, 3-week cycles of treatment

Outcome Measure Data

Analysis Population Description

Evaluable Population

Arm/Group Title	HER2-Neu Negative	HER2-Neu Positive
Arm/Group Description	Dose and route per treatment cycle (Q3W): Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 HER2-neu negative: capecitabine + docetaxel Duration: Four 3-week treatment cycles	Dose and route per treatment cycle (Q3W): Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly HER2-neu positive: capecitabine + docetaxel + trastuzumab Duration: Four 3-week treatment cycles
Measure Participants	101	28
Number (95% Confidence Interval) [percentage of participants]	23.8 19.5%	23.5 69.1%

4. Secondary Outcome

Title	Percentage of Participants With Local Recurrence
Description	Local recurrence was defined as evidence of recurrent carcinoma in the same breast where it was diagnosed initially before preoperative treatment.
Time Frame	30 - 1102 days

Outcome Measure Data

Analysis Population Description

Postoperative Response Evaluable Population

Arm/Group Title	HER2-Neu Negative	HER2-Neu Positive
Arm/Group Description	Dose and route per treatment cycle (Q3W): Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 HER2-neu negative: capecitabine + docetaxel Duration: Four 3-week treatment cycles	Dose and route per treatment cycle (Q3W): Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly HER2-neu positive: capecitabine + docetaxel + trastuzumab Duration: Four 3-week treatment cycles
Measure Participants	101	28
Number (95% Confidence Interval) [percentage of participants]	3.1 2.5%	3.7 10.9%

5. Secondary Outcome

Title	Participants With Disease-Free Survival
Description	Disease-free survival was defined as the time from date of surgery to date of first evidence of cancer recurrence in the breast (ie, local or distant recurrence or contra lateral disease) or death from any cause, whichever came first. Patients who were alive or withdrawn from the study and had no evidence of disease recurrence and for whom there was CRF evidence that evaluations had been made were censored at the date of the last clinical follow-up assessment when the patient was known to be disease free.
Time Frame	30 - 1102 days

Outcome Measure Data

Analysis Population Description

The analysis was done on the Postoperative Response Evaluable Population.

Arm/Group Title	HER2-Neu Negative	HER2-Neu Positive
Arm/Group Description	Dose and route per treatment cycle (Q3W): Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 HER2-neu negative: capecitabine + docetaxel Duration: Four 3-week treatment cycles	Dose and route per treatment cycle (Q3W): Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly HER2-neu positive: capecitabine + docetaxel + trastuzumab Duration: Four 3-week treatment cycles
Measure Participants	98	27
Number [participants]	92 75.4%	25 73.5%

6. Secondary Outcome

Title	Participants With Overall Survival
Description	Overall survival was defined as the time from date of start of study treatment to the date of death, regardless of the cause of death. Patients who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Patients without follow-up assessment were censored at the day of the last dose. Patients with no post-baseline information were censored at the start of study treatment.
Time Frame	22 - 1191 days

Outcome Measure Data

Analysis Population Description

The analysis was done on the post-operative Response Evaluable Population.

Arm/Group Title	HER2-Neu Negative	HER2-Neu Positive
Arm/Group Description	Dose and route per treatment cycle (Q3W): Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 HER2-neu negative: capecitabine + docetaxel Duration: Four 3-week treatment cycles	Dose and route per treatment cycle (Q3W): Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly HER2-neu positive: capecitabine + docetaxel + trastuzumab Duration: Four 3-week treatment cycles
Measure Participants	122	34
Number [participants]	118 96.7%	32 94.1%

Adverse Events

Time Frame	Cycle 1, Cycle 2, Cycle 3, Cycle 4, at Surgery, and the month 1 visit during the postoperative follow-up period
Adverse Event Reporting Description	Intensity of AEs was graded according to the NCI CTCAE version 3.0 on a 5-point scale (grade 1 to 5), clinical laboratory parameters (hematology, chemistry, and urinalysis as clinically indicated), and vital signs.
Arm/Group Title	HER2-Neu Negative		HER2-Neu Positive
Arm/Group Description	Dose and route per treatment cycle (Q3W): Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 HER2-neu negative: capecitabine + docetaxel Duration: Four 3-week treatment cycles		Dose and route per treatment cycle (Q3W): Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly HER2-neu positive: capecitabine + docetaxel + trastuzumab Duration: Four 3-week treatment cycles
All Cause Mortality
	HER2-Neu Negative		HER2-Neu Positive
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	HER2-Neu Negative		HER2-Neu Positive
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	15/122 (12.3%)		7/34 (20.6%)
Blood and lymphatic system disorders
febrile neutropenia	4/122 (3.3%)		1/34 (2.9%)
Neutropenia	0/122 (0%)		1/34 (2.9%)
Cardiac disorders
Angina unstable	1/122 (0.8%)		0/34 (0%)
Coronary artery disease	1/122 (0.8%)		0/34 (0%)
Myocardial infarction	1/122 (0.8%)		0/34 (0%)
Gastrointestinal disorders
Diarrhoea	2/122 (1.6%)		0/34 (0%)
Colitis	1/122 (0.8%)		0/34 (0%)
General disorders
Pyrexia	2/122 (1.6%)		0/34 (0%)
Chest pain	1/122 (0.8%)		0/34 (0%)
Infections and infestations
Pneumonia	1/122 (0.8%)		1/34 (2.9%)
Catheter site cellulitis	1/122 (0.8%)		0/34 (0%)
Infection	0/122 (0%)		1/34 (2.9%)
Perirectal abscess	0/122 (0%)		1/34 (2.9%)
Staphylococcal infection	1/122 (0.8%)		0/34 (0%)
Urinary tract infection	1/122 (0.8%)		0/34 (0%)
Investigations
International normalised ratio increased	0/122 (0%)		1/34 (2.9%)
Prothrombin time prolonged	0/122 (0%)		1/34 (2.9%)
Metabolism and nutrition disorders
Dehydration	1/122 (0.8%)		0/34 (0%)
Nervous system disorders
Presyncope	0/122 (0%)		1/34 (2.9%)
Renal and urinary disorders
Nephrolithiasis	0/122 (0%)		1/34 (2.9%)
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism	1/122 (0.8%)		0/34 (0%)
Respiratory failure	1/122 (0.8%)		0/34 (0%)
Vascular disorders
Hypotension	0/122 (0%)		1/34 (2.9%)
Other (Not Including Serious) Adverse Events
	HER2-Neu Negative		HER2-Neu Positive
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	121/122 (99.2%)		33/34 (97.1%)
Blood and lymphatic system disorders
Neutropenia	31/122 (25.4%)		9/34 (26.5%)
Anaemia	7/122 (5.7%)		10/34 (29.4%)
Eye disorders
Lacrimation increased	11/122 (9%)		4/34 (11.8%)
Eye irritation	1/122 (0.8%)		2/34 (5.9%)
Gastrointestinal disorders
Nausea	57/122 (46.7%)		19/34 (55.9%)
Diarrhoea	51/122 (41.8%)		19/34 (55.9%)
Constipation	30/122 (24.6%)		6/34 (17.6%)
Stomatitis	18/122 (14.8%)		14/34 (41.2%)
Dyspepsia	22/122 (18%)		6/34 (17.6%)
Vomiting	24/122 (19.7%)		4/34 (11.8%)
Abdominal pain	11/122 (9%)		1/34 (2.9%)
Gastrooesophageal reflux disease	5/122 (4.1%)		2/34 (5.9%)
Abdominal pain upper	4/122 (3.3%)		2/34 (5.9%)
Haemorrhoids	4/122 (3.3%)		2/34 (5.9%)
Rectal haemorrhage	2/122 (1.6%)		2/34 (5.9%)
General disorders
Fatigue	62/122 (50.8%)		20/34 (58.8%)
Mucosal inflammation	21/122 (17.2%)		5/34 (14.7%)
Oedema peripheral	17/122 (13.9%)		4/34 (11.8%)
Pyrexia	7/122 (5.7%)		5/34 (14.7%)
Pain	6/122 (4.9%)		6/34 (17.6%)
Chest pain	7/122 (5.7%)		1/34 (2.9%)
Chills	5/122 (4.1%)		4/34 (11.8%)
Asthenia	4/122 (3.3%)		2/34 (5.9%)
Chest discomfort	2/122 (1.6%)		2/34 (5.9%)
Catheter site pain	1/122 (0.8%)		2/34 (5.9%)
Infections and infestations
Upper respiratory tract infection	3/122 (2.5%)		2/34 (5.9%)
Vaginal infection	2/122 (1.6%)		2/34 (5.9%)
Metabolism and nutrition disorders
Anorexia	10/122 (8.2%)		0/34 (0%)
Dehydration	5/122 (4.1%)		2/34 (5.9%)
Hyperglycaemia	5/122 (4.1%)		3/34 (8.8%)
Decreased appetite	4/122 (3.3%)		2/34 (5.9%)
Musculoskeletal and connective tissue disorders
Myalgia	11/122 (9%)		3/34 (8.8%)
Pain in extremity	12/122 (9.8%)		2/34 (5.9%)
Arthralgia	6/122 (4.9%)		3/34 (8.8%)
Bone pain	7/122 (5.7%)		1/34 (2.9%)
Nervous system disorders
Headache	20/122 (16.4%)		4/34 (11.8%)
Dysgeusia	17/122 (13.9%)		3/34 (8.8%)
Neuropathy peripheral	17/122 (13.9%)		2/34 (5.9%)
Paraesthesia	8/122 (6.6%)		3/34 (8.8%)
Dizziness	8/122 (6.6%)		2/34 (5.9%)
Peripheral sensory neuropathy	7/122 (5.7%)		2/34 (5.9%)
Psychiatric disorders
Insomnia	27/122 (22.1%)		12/34 (35.3%)
Anxiety	10/122 (8.2%)		4/34 (11.8%)
Depression	5/122 (4.1%)		2/34 (5.9%)
Reproductive system and breast disorders
Breast pain	7/122 (5.7%)		0/34 (0%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea	12/122 (9.8%)		5/34 (14.7%)
Oropharyngeal pain	12/122 (9.8%)		4/34 (11.8%)
Epistaxis	10/122 (8.2%)		3/34 (8.8%)
Cough	6/122 (4.9%)		4/34 (11.8%)
Rhinorrhoea	2/122 (1.6%)		3/34 (8.8%)
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome	57/122 (46.7%)		21/34 (61.8%)
Alopecia	59/122 (48.4%)		12/34 (35.3%)
Rash	29/122 (23.8%)		6/34 (17.6%)
Nail disorder	10/122 (8.2%)		5/34 (14.7%)
Dry skin	7/122 (5.7%)		2/34 (5.9%)
Erythema	7/122 (5.7%)		2/34 (5.9%)
Pruritus	6/122 (4.9%)		2/34 (5.9%)
Vascular disorders
Flushing	6/122 (4.9%)		2/34 (5.9%)

Limitations/Caveats

[Not Specified]

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.