NCT00885755 is a Phase 2 clinical trial of Standard taxane therapy in Breast Cancer, sponsored by Hoffmann-La Roche.

Who is sponsoring NCT00885755?

NCT00885755 is sponsored by Hoffmann-La Roche.

What drugs are being tested in NCT00885755?

Interventions in NCT00885755: Standard taxane therapy, capecitabine [Xeloda], trastuzumab [Herceptin].

What condition does NCT00885755 study?

NCT00885755 studies Breast Cancer.

Is NCT00885755 still recruiting?

NCT00885755 is currently completed. Last updated 29 March 2018.

Are results published for NCT00885755?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-03-29 · How we verify

NCT00885755

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of Herceptin (Trastuzumab)and Biomarkers in Patients With HER2-Positive Metastatic Breast Cancer

Completed Phase 2 Results posted Last updated 29 March 2018

What this trial tests

Phase 2 trial testing Standard taxane therapy in Breast Cancer in 33 participants. Completed in 18 February 2013.

Timeline

13 August 2009

Primary endpoint
18 February 2013

18 February 2013

Quick facts

Lead sponsor	Hoffmann-La Roche
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	33
Start date	13 August 2009
Primary completion	18 February 2013
Estimated completion	18 February 2013
Sites	13 locations across Sweden, United Kingdom, Australia, Spain

Drugs / interventions tested

Standard taxane therapy — full drug profile →
capecitabine [Xeloda]
trastuzumab [Herceptin]

Conditions studied

Breast Cancer — all drugs for Breast Cancer →

Sponsor

Hoffmann-La Roche — full company profile →

Who can join

18 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Part I: Progression Free Survival (PFS) by Biomarker Primary · End of first 2 Cycles (Weeks 3 and 6), every 3 Cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months

Progression was defined as an increase by at least 20 percent (%) from the smallest value in the Sum of Longest Diameter (SLD) of lesions. Biomarkers investigated: p95 human epidermal growth factor receptor 2 (p95HER2) positive (+ve) and negative (-ve) , insulin growth factor-1 receptor (IGF1R) less than (\<) median and greater than or equal to (≥) median membrane H score, c-MET \<median and ≥median membrane H score, phosphatase and tensin homolog gene (PTEN) \<median and ≥median cytoplasm H score, HER2 \<median and ≥median membrane H score, phosphatidylinositol-3-kinase (PI3K) catalytic subun

p95 HER2 +ve (n=9,0)

Group	Value	95% CI
Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)	NA	3.384 – NA
Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks	NA	NA – NA

p95 HER2 -ve (n=15,1)

Group	Value	95% CI
Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)	13.963	7.261 – 22.407
Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks	1.216	NA – NA

IGF1R <median (n=12,0)

Group	Value	95% CI
Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)	12.649	4.698 – NA
Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks	NA	NA – NA

IGF1R ≥median (n=14,1)

Group	Value	95% CI
Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)	22.209	7.261 – NA
Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks	1.216	NA – NA

c-MET <median (n=10,1)

Group	Value	95% CI
Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)	18.595	3.384 – NA
Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks	1.216	NA – NA

c-MET ≥median (n=15,0)

Group	Value	95% CI
Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)	13.733	7.031 – NA
Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks	NA	NA – NA

PTEN <median (n=12,0)

Group	Value	95% CI
Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)	22.209	5.914 – NA
Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks	NA	NA – NA

PTEN ≥median (n=14,1)

Group	Value	95% CI
Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)	13.963	6.374 – 31.179
Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks	1.216	NA – NA

Part I: TTP in Intent to Treat (ITT) Population Secondary · End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months

TTP was determined as the time in months from the date of screening until first progression. In participants with measurable disease, progression was defined according to RECIST (SLD increased by at least 20% from the smallest value on study \[including baseline, if that is the smallest\]). In participants with non-measurable disease, progression was defined as the presence of new lesions or unequivocal progression during treatment.

Group	Value	95% CI
Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)	22.21	9.53 – NA
Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks	1.22	NA – NA

Part II: Progression Free Survival (PFS) by Biomarker Primary · End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months

PFS was calculated from first study medication in Part II to date of progression or death.The relationship between PFS and the following biomarker variables was investigated in each of study Part 1 and 2: p95HER2 +ve and -ve population, IGF1R \<median and ≥ median membrane H score, c-MET \<median and ≥median membrane H score, PTEN \<median and ≥median cytoplasm H score, HER2 \<median and ≥median membrane H score, PI3K catalytic subunit WT and M, and FC gamma receptors IIIa, IIa and IIb Phenotypes FF, VF and VV, HH, HR and RR, and II, IT and TT.

p95 +ve (n=2,0)

Group	Value	95% CI
Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)	8.148	NA – NA
Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks	NA	NA – NA

p95 -ve (n=5,1)

Group	Value	95% CI
Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)	3.450	0.854 – 8.115
Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks	13.832	NA – NA

IGF1R <median (n=4,0)

Group	Value	95% CI
Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)	8.115	0.854 – 8.115
Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks	NA	NA – NA

IGF1R ≥median (n=4,1)

Group	Value	95% CI
Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)	4.074	1.971 – 8.148
Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks	13.832	NA – NA

c-MET<median (n=3,1)

Group	Value	95% CI
Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)	4.698	3.450 – 4.698
Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks	13.832	NA – NA

c-MET≥median (n=4,0)

Group	Value	95% CI
Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)	5.043	0.854 – 8.148
Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks	NA	NA – NA

PTEN <median (n=4,0)

Group	Value	95% CI
Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)	4.698	1.971 – 8.115
Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks	NA	NA – NA

PTEN ≥median (n=3,1)

Group	Value	95% CI
Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)	3.450	0.854 – 8.148
Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks	13.832	NA – NA

Part I: Time to Progression (TTP) by Biomarker Primary · End of first 2 Cycles (Weeks 3 and 6), every 3 Cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 weeks

Progression was defined as an increase by at least 20% from the smallest value in the SLD of lesions.TTP was determined as the time in months from the date of screening until first progression.The relationship between PFS and the following biomarker variables was investigated in each of study Part 1 and 2: p95 HER2 +ve and -ve population, IGF1R \<median and ≥median, c-MET \<median and ≥median, PTEN \<median and ≥median, HER2 \<median and ≥median, PI3K catalytic subunit WT and M, and FC gamma receptors IIIa, IIa and IIb Phenotypes FF, VF and VV, HH, HR and RR, and II, IT and TT . The correlatio

p95 +ve (n=9,0)

Group	Value	95% CI
Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)	NA	3.384 – NA
Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks	NA	NA – NA

p95 -ve (n=15,1)

Group	Value	95% CI
Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)	13.963	7.261 – 22.407
Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks	1.216	NA – NA

IGF1R <median (n=12,0)

Group	Value	95% CI
Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)	11.335	4.698 – NA
Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks	NA	NA – NA

IGF1R ≥median (n=14,1)

Group	Value	95% CI
Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)	22.407	5.914 – NA
Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks	1.216	NA – NA

c-MET <median (n=10,1)

Group	Value	95% CI
Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)	31.179	3.384 – NA
Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks	1.216	NA – NA

c-MET ≥median (n=15,0)

Group	Value	95% CI
Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)	22.209	6.374 – NA
Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks	NA	NA – NA

PTEN <median (n=12,0)

Group	Value	95% CI
Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)	22.209	5.914 – NA
Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks	NA	NA – NA

PTEN ≥median (n=14,1)

Group	Value	95% CI
Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)	13.963	6.374 – 31.179
Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks	1.216	NA – NA

Part I: PFS in ITT Population Secondary · End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months

PFS was determined as the time in months from the date of screening until first progression. In participants with measurable disease, progression was defined according to RECIST (SLD increased by at least 20% from the smallest value on study \[including baseline, if that is the smallest\]).. In participants with non-measurable disease, progression was defined as the presence of new lesions or unequivocal progression during treatment.

Group	Value	95% CI
Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)	18.60	8.08 – NA
Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks	1.22	NA – NA

Part II: TTP in Intent to Treat (ITT) Population Secondary · End of first 2 Cycles (Weeks 3 and 6), every 3 Cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months

TTP was calculated from first study medication in Part II to date of progression. In participants with measurable disease progression was defined according to RECIST(SLD increased by at least 20% from the smallest value on study \[including baseline, if that is the smallest\]). In participants with non-measurable disease, progression was defined as the presence of new lesions or unequivocal progression during treatment.

Group	Value	95% CI
Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)	5.65	2.99 – 8.15
Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks	13.83	NA – NA

Part II: PFS in ITT Population Secondary · End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months

PFS was calculated from first study medication in Part II to date of progression or death. In participants with measurable disease progression was defined according to RECIST (SLD increased by at least 20% from the smallest value on study \[including baseline, if that is the smallest\]). In participants with non-measurable disease, progression was defined as the presence of new lesions or unequivocal progression during treatment.

Group	Value	95% CI
Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)	5.65	2.99 – 24.21
Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks	13.83	NA – NA

Overall Survival in Per Protocol Population Secondary · End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until death (up to 46 months)

Overall survival was calculated in months from the day of screening until death.

Group	Value	95% CI
Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)	36.40	6.57 – 40.28

Overall Survival in ITT Population Secondary · End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until death (up to 46 months)

Overall survival was calculated in months from the day of screening until death.

Group	Value	95% CI
Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)	NA	6.57 – 40.28

Part I and II: Percentage of Participants With a Best Overall Response of CR or PR in ITT Population Secondary · End of first 2 Cycles (Weeks 3 and 6), every 3 Cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months

Best Overall response was defined according to RECIST. CR: disappearance of all target lesions and all pathological lymph nodes below 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions.

Part I: Responders (n=20)

Group	Value	95% CI
Group A: Trastuzumab+Taxane /Capcetabine (6 Weeks)	75.0

Part I: Non-Responders (n=20)

Group	Value	95% CI
Group A: Trastuzumab+Taxane /Capcetabine (6 Weeks)	20.0

Part I: Missing (n=20)

Group	Value	95% CI
Group A: Trastuzumab+Taxane /Capcetabine (6 Weeks)	5.0

Part II: Responders (n=9)

Group	Value	95% CI
Group A: Trastuzumab+Taxane /Capcetabine (6 Weeks)	11.1

Part II: Non-Responders (n=9)

Group	Value	95% CI
Group A: Trastuzumab+Taxane /Capcetabine (6 Weeks)	88.9

Part II: Missing (n=9)

Group	Value	95% CI
Group A: Trastuzumab+Taxane /Capcetabine (6 Weeks)	0.0

Part II: TTP by Biomarker Primary · End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months

TTP was calculated from first study medication in Part II to date of progression. The relationship between TTP and the following biomarker variables was investigated in each of study Part 1 and 2: p95 HER2 +ve and -ve population, IGF1R \<median and ≥median, c-MET \<median and ≥median, PTEN \<median and ≥median, HER2 \<median and ≥median, PI3K catalytic subunit WT and M, and FC gamma receptors IIIa, IIa and IIb Phenotypes FF, VF and VV, HH, HR and RR, and II, IT and TT .

p95 HER2 +ve (n=2,0)

Group	Value	95% CI
Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)	8.148	NA – NA
Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks	NA	NA – NA

p95 HER2 -ve (n=5,1)

Group	Value	95% CI
Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)	3.450	0.854 – 8.115
Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks	13.832	NA – NA

IGF1R <median (n=4,0)

Group	Value	95% CI
Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)	8.115	0.854 – 8.115
Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks	NA	NA – NA

IGF1R ≥median (n=4,1)

Group	Value	95% CI
Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)	4.074	1.971 – 8.148
Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks	13.832	NA – NA

c-MET <median (n=3,1)

Group	Value	95% CI
Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)	4.698	3.450 – 4.698
Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks	13.832	NA – NA

c-MET ≥median (n=4,0)

Group	Value	95% CI
Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)	5.043	0.854 – 8.148
Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks	NA	NA – NA

PTEN <median (n=4,0)

Group	Value	95% CI
Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)	4.698	1.971 – 8.115
Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks	NA	NA – NA

PTEN ≥median (n=3,1)

Group	Value	95% CI
Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)	3.450	0.854 – 8.148
Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks	13.832	NA – NA

Part I: Percentage of Participants With a Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progrerssive Disease (PD) by Biomarker Primary · End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 weeks

BOR was defined according to the Response Evaluation Criteria In Solid Tumors (RECIST). CR: disappearance of all target lesions and all pathological lymph nodes below 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions. The relationship between best response and the following biomarkers was investig

p95 HER2 +ve CR (n=5)

Group	Value	95% CI
Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)	0.0

p95 HER2 +ve PR (n=5)

Group	Value	95% CI
Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)	25.0

p95 HER2 +ve SD (n=5)

Group	Value	95% CI
Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)	50.0

p95 HER2 +ve PD (n=5)

Group	Value	95% CI
Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)	25.0

p95 HER2 -ve CR (n=12)

Group	Value	95% CI
Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)	0.0

p95 HER2 -ve PR (n=12)

Group	Value	95% CI
Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)	91.7

p95 HER2 -ve SD (n=12)

Group	Value	95% CI
Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)	8.3

p95 HER2 -ve PD (n=12)

Group	Value	95% CI
Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)	0.0

Adverse events — posted to ClinicalTrials.gov

Time frame: From the date of Screening until 4 weeks after the last visit of the participant. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

All Participants

Serious: 9/33 (27%)

Deaths: —

Serious adverse events (11 terms)

Reaction	System	All Participants
Pyrexia	General disorders	—
Chest pain	General disorders	—
Medical device complication	General disorders	—
Cellulitis	Infections and infestations	—
Sepsis	Infections and infestations	—
Febrile neutropenia	Blood and lymphatic system disorders	—
Cardiac failure	Cardiac disorders	—
Hip fracture	Injury, poisoning and procedural complications	—
Back pain	Musculoskeletal and connective tissue disorders	—
Menorrhagia	Reproductive system and breast disorders	—
Thrombosis	Vascular disorders	—

Other adverse events (116 terms — click to expand)

Reaction	System	All Participants
Nail disorder	Skin and subcutaneous tissue disorders	—
Rash	Skin and subcutaneous tissue disorders	—
Fatigue	General disorders	—
Diarrhoea	Gastrointestinal disorders	—
Nausea	Gastrointestinal disorders	—
Alopecia	Skin and subcutaneous tissue disorders	—
Peripheral sensory neuropathy	Nervous system disorders	—
Headache	Nervous system disorders	—
Vomiting	Gastrointestinal disorders	—
Arthralgia	Musculoskeletal and connective tissue disorders	—
Back pain	Musculoskeletal and connective tissue disorders	—
Dyspepsia	Gastrointestinal disorders	—
Influenza like illness	General disorders	—
Decreased appetite	Metabolism and nutrition disorders	—
Oedema peripheral	General disorders	—
Procedural pain	Injury, poisoning and procedural complications	—
Palmer-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	—
Dysgeusia	Nervous system disorders	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—
Constipation	Gastrointestinal disorders	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	—
Upper respiratory tract infection	Infections and infestations	—
Cough	Respiratory, thoracic and mediastinal disorders	—
Hot flush	Vascular disorders	—
Stomatitis	Gastrointestinal disorders	—
Pain	General disorders	—
Scab	Skin and subcutaneous tissue disorders	—
Nasopharyngitis	Infections and infestations	—
Rhinitis	Infections and infestations	—
Asthenia	General disorders	—
Mucosal inflammation	General disorders	—
Chest pain	General disorders	—
Dry skin	Skin and subcutaneous tissue disorders	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—
Myalgia	Musculoskeletal and connective tissue disorders	—
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	—
Abdominal Pain	Gastrointestinal disorders	—
Neuropathy peripheral	Nervous system disorders	—

Most-reported serious reactions: Pyrexia, Chest pain, Medical device complication, Cellulitis, Sepsis, Febrile neutropenia, Cardiac failure, Hip fracture.

Data from ClinicalTrials.gov NCT00885755 adverse events section.

Sponsor's own description

This single arm study will evaluate alterations in molecular marker expression in HER2-positive targeted therapy, and will evaluate the effect of continued treatment with Herceptin and Xeloda beyond progression following initial Herceptin-taxane chemotherapy. Patients who develop progressive disease will receive first-line Herceptin (8mg/kg iv loading dose and 6mg/kg iv every 3 weeks) + taxane therapy. patients who develop progressive disease within 9 weeks of treatment will continue treatment with Herceptin in combination with Xeloda (1000mg/m2 po bid on days 1-14 of each 3-week cycle).Biopsies of tumor tissue will be taken for biomarker and gene profiling evaluation. The anticipated time on study treatment is until disease progression, intolerable side effects or patient choice, and the target sample size is 100 individuals.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Testing for her2 in breast cancer: current pathology challenges faced in Canada.
Hanna W, Barnes P, Berendt R, Chang M, et al · · 2012 · cited 5× · PMID 23300357 · DOI 10.3747/co.19.1173

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00885755 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hoffmann-La Roche
Last refreshed: 29 March 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00885755.

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