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

This study has been completed.

Sponsor:

Information provided by:

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT00127933

First received: August 5, 2005

Last updated: July 13, 2011

Last verified: July 2011

History of Changes

Results First Received: March 30, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Breast Cancer
Interventions:	Drug: capecitabine [Xeloda] Drug: Taxotere Drug: Herceptin (HER2-neu positive patients only)

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
HER2-Neu Negative	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
HER2-Neu Positive	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

Description

HER2-Neu Negative

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

HER2-Neu Positive

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

Participant Flow: Overall Study

	HER2-Neu Negative	HER2-Neu Positive
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
Randomized but not dosed	1	0

Baseline Characteristics

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Reporting Groups

	Description
HER2-Neu Negative	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
HER2-Neu Positive	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	Total of all reporting groups

Description

HER2-Neu Negative

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

HER2-Neu Positive

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

Total of all reporting groups

Baseline Measures

	HER2-Neu Negative	HER2-Neu Positive	Total
Number of Participants [units: participants]	122	34	156
Age ^[1] [units: years] Mean ± Standard Deviation	51.0 ± 11.20	52.2 ± 9.36	51.3 ± 10.79
Gender [units: participants]
Female	122	34	156
Male	0	0	0

[1]	Safety Population

Outcome Measures

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1. Primary:

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

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2. Secondary:

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

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3. Secondary:

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

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4. Secondary:

Percentage of Participants With Local Recurrence [ Time Frame: 30 - 1102 days ]

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5. Secondary:

Participants With Disease-Free Survival [ Time Frame: 30 - 1102 days ]

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6. Secondary:

Participants With Overall Survival [ Time Frame: 22 - 1191 days ]

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Serious Adverse Events

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Other Adverse Events

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Time Frame	Cycle 1, Cycle 2, Cycle 3, Cycle 4, at Surgery, and the month 1 visit during the postoperative follow-up period
Additional 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.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

	Description
HER2-Neu Negative	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
HER2-Neu Positive	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

Description

HER2-Neu Negative

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

HER2-Neu Positive

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

Other Adverse Events

	HER2-Neu Negative	HER2-Neu Positive
Total, other (not including serious) adverse events
# participants affected / at risk	121/122	33/34
Blood and lymphatic system disorders
Neutropenia ^{† 1}
# participants affected / at risk	31/122 (25.41%)	9/34 (26.47%)
Anaemia ^{† 1}
# participants affected / at risk	7/122 (5.74%)	10/34 (29.41%)
Eye disorders
Lacrimation increased ^{† 1}
# participants affected / at risk	11/122 (9.02%)	4/34 (11.76%)
Eye irritation ^{† 1}
# participants affected / at risk	1/122 (0.82%)	2/34 (5.88%)
Gastrointestinal disorders
Nausea ^{† 1}
# participants affected / at risk	57/122 (46.72%)	19/34 (55.88%)
Diarrhoea ^{† 1}
# participants affected / at risk	51/122 (41.80%)	19/34 (55.88%)
Constipation ^{† 1}
# participants affected / at risk	30/122 (24.59%)	6/34 (17.65%)
Stomatitis ^{† 1}
# participants affected / at risk	18/122 (14.75%)	14/34 (41.18%)
Dyspepsia ^{† 1}
# participants affected / at risk	22/122 (18.03%)	6/34 (17.65%)
Vomiting ^{† 1}
# participants affected / at risk	24/122 (19.67%)	4/34 (11.76%)
Abdominal pain ^{† 1}
# participants affected / at risk	11/122 (9.02%)	1/34 (2.94%)
Gastrooesophageal reflux disease ^{† 1}
# participants affected / at risk	5/122 (4.10%)	2/34 (5.88%)
Abdominal pain upper ^{† 1}
# participants affected / at risk	4/122 (3.28%)	2/34 (5.88%)
Haemorrhoids ^{† 1}
# participants affected / at risk	4/122 (3.28%)	2/34 (5.88%)
Rectal haemorrhage ^{† 1}
# participants affected / at risk	2/122 (1.64%)	2/34 (5.88%)
General disorders
Fatigue ^{† 1}
# participants affected / at risk	62/122 (50.82%)	20/34 (58.82%)
Mucosal inflammation ^{† 1}
# participants affected / at risk	21/122 (17.21%)	5/34 (14.71%)
Oedema peripheral ^{† 1}
# participants affected / at risk	17/122 (13.93%)	4/34 (11.76%)
Pyrexia ^{† 1}
# participants affected / at risk	7/122 (5.74%)	5/34 (14.71%)
Pain ^{† 1}
# participants affected / at risk	6/122 (4.92%)	6/34 (17.65%)
Chest pain ^{† 1}
# participants affected / at risk	7/122 (5.74%)	1/34 (2.94%)
Chills ^{† 1}
# participants affected / at risk	5/122 (4.10%)	4/34 (11.76%)
Asthenia ^{† 1}
# participants affected / at risk	4/122 (3.28%)	2/34 (5.88%)
Chest discomfort ^{† 1}
# participants affected / at risk	2/122 (1.64%)	2/34 (5.88%)
Catheter site pain ^{† 1}
# participants affected / at risk	1/122 (0.82%)	2/34 (5.88%)
Infections and infestations
Upper respiratory tract infection ^{† 1}
# participants affected / at risk	3/122 (2.46%)	2/34 (5.88%)
Vaginal infection ^{† 1}
# participants affected / at risk	2/122 (1.64%)	2/34 (5.88%)
Metabolism and nutrition disorders
Anorexia ^{† 1}
# participants affected / at risk	10/122 (8.20%)	0/34 (0.00%)
Dehydration ^{† 1}
# participants affected / at risk	5/122 (4.10%)	2/34 (5.88%)
Hyperglycaemia ^{† 1}
# participants affected / at risk	5/122 (4.10%)	3/34 (8.82%)
Decreased appetite ^{† 1}
# participants affected / at risk	4/122 (3.28%)	2/34 (5.88%)
Musculoskeletal and connective tissue disorders
Myalgia ^{† 1}
# participants affected / at risk	11/122 (9.02%)	3/34 (8.82%)
Pain in extremity ^{† 1}
# participants affected / at risk	12/122 (9.84%)	2/34 (5.88%)
Arthralgia ^{† 1}
# participants affected / at risk	6/122 (4.92%)	3/34 (8.82%)
Bone pain ^{† 1}
# participants affected / at risk	7/122 (5.74%)	1/34 (2.94%)
Nervous system disorders
Headache ^{† 1}
# participants affected / at risk	20/122 (16.39%)	4/34 (11.76%)
Dysgeusia ^{† 1}
# participants affected / at risk	17/122 (13.93%)	3/34 (8.82%)
Neuropathy peripheral ^{† 1}
# participants affected / at risk	17/122 (13.93%)	2/34 (5.88%)
Paraesthesia ^{† 1}
# participants affected / at risk	8/122 (6.56%)	3/34 (8.82%)
Dizziness ^{† 1}
# participants affected / at risk	8/122 (6.56%)	2/34 (5.88%)
Peripheral sensory neuropathy ^{† 1}
# participants affected / at risk	7/122 (5.74%)	2/34 (5.88%)
Psychiatric disorders
Insomnia ^{† 1}
# participants affected / at risk	27/122 (22.13%)	12/34 (35.29%)
Anxiety ^{† 1}
# participants affected / at risk	10/122 (8.20%)	4/34 (11.76%)
Depression ^{† 1}
# participants affected / at risk	5/122 (4.10%)	2/34 (5.88%)
Reproductive system and breast disorders
Breast pain ^{† 1}
# participants affected / at risk	7/122 (5.74%)	0/34 (0.00%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea ^{† 1}
# participants affected / at risk	12/122 (9.84%)	5/34 (14.71%)
Oropharyngeal pain ^{† 1}
# participants affected / at risk	12/122 (9.84%)	4/34 (11.76%)
Epistaxis ^{† 1}
# participants affected / at risk	10/122 (8.20%)	3/34 (8.82%)
Cough ^{† 1}
# participants affected / at risk	6/122 (4.92%)	4/34 (11.76%)
Rhinorrhoea ^{† 1}
# participants affected / at risk	2/122 (1.64%)	3/34 (8.82%)
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome ^{† 1}
# participants affected / at risk	57/122 (46.72%)	21/34 (61.76%)
Alopecia ^{† 1}
# participants affected / at risk	59/122 (48.36%)	12/34 (35.29%)
Rash ^{† 1}
# participants affected / at risk	29/122 (23.77%)	6/34 (17.65%)
Nail disorder ^{† 1}
# participants affected / at risk	10/122 (8.20%)	5/34 (14.71%)
Dry skin ^{† 1}
# participants affected / at risk	7/122 (5.74%)	2/34 (5.88%)
Erythema ^{† 1}
# participants affected / at risk	7/122 (5.74%)	2/34 (5.88%)
Pruritus ^{† 1}
# participants affected / at risk	6/122 (4.92%)	2/34 (5.88%)
Vascular disorders
Flushing ^{† 1}
# participants affected / at risk	6/122 (4.92%)	2/34 (5.88%)

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 12.0

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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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Medical Communications
Organization: Hoffman-LaRoche
phone: 800-821-8590

No publications provided

Responsible Party:	Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00127933 History of Changes
Other Study ID Numbers:	ML18530
Study First Received:	August 5, 2005
Results First Received:	March 30, 2011
Last Updated:	July 13, 2011
Health Authority:	United States: Food and Drug Administration

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