A Study of Herceptin (Trastuzumab) in Women With Metastat... | NCT00475670

NCT00475670

Status Module

Sponsor/Collaborators Module

Oversight Module

No data available

No data is available for this block.

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Trastuzumab Monotherapy	Active Comparator	Participants received an initial loading dose of 4 milligrams per kilogram (mg/kg) trastuzumab intravenous (i.v.) on Day 1, followed by 2mg/kg i.v. weekly, or an initial loading dose of 8 mg/kg i.v. loading dose on Day 1, followed by 6 mg/kg i.v. every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.	Drug: Trastuzumab
Trastuzumab, Taxane	Experimental	Participant received an initial loading dose of 4 mg/kg trastuzumab i.v. on Day 1, followed by 2mg/kg i.v. weekly, or an initial loading dose of 8 mg/kg i.v. loading dose, followed by 6 mg/kg i.v. every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death; and concomitant taxane, which is either 100 milligrams per square meter (mg/m2) docetaxel i.v. every 3 weeks, or 75 mg/m2 weekly or 175 mg/m2 every 3 weeks paclitaxel for at least 18 weeks, or more at the discretion of the investigator.	Drug: Trastuzumab Drug: Taxane (docetaxel or paclitaxel)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Trastuzumab	Drug	4 mg/kg i.v. loading dose on Day 1, followed by 2 mg/kg i.v. weekly; or 8 mg/kg i.v. loading dose, followed by 6 mg/kg i.v. every 3 weeks until disease progression, unacceptable toxicity, withdrawal or death.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) According to the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 Guidelines	CR was defined for target lesions (TLs) as the disappearance of all lesions, and for nontarget lesions (NTLs) as the disappearance of all nontarget nonmeasurable lesions. PR was defined for TLs as at least a 30 percent (%) decrease from baseline (BL) in the sum of longest diameter (SLD) of TLs. 95% confidence interval for one-sample binomial using Pearson-Clopper method.	Baseline (BL); Day 1 of Weeks 7, 13, 19, 25, 37, and 52, at the last administration of study treatment, every 24 weeks thereafter until disease progression for up to 6 months after the last participant was recruited

Secondary Outcomes

Measure	Description	Time Frame
Duration of Response - Percentage of Participants With Progressive Disease or Death	Duration of response was defined as the time from first confirmed CR or PR until death or progressive disease (PD). For TLs, PD was defined as at least a 20% increase in the SLD of the TL, taking as reference the smallest SLD recorded since the beginning of treatment or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of one or more new lesions or unequivocal progression of existing non target non-measurable lesions. Participants were censored at the date of the last tumor assessment.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24051172	Derived	Lang I, Bell R, Feng FY, Lopez RI, Jassem J, Semiglazov V, Al-Sakaff N, Heinzmann D, Chang J. Trastuzumab retreatment after relapse on adjuvant trastuzumab therapy for human epidermal growth factor receptor 2-positive breast cancer: final results of the Retreatment after HErceptin Adjuvant trial. Clin Oncol (R Coll Radiol). 2014 Feb;26(2):81-9. doi: 10.1016/j.clon.2013.08.011. Epub 2013 Sep 17.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Trastuzumab Monotherapy	Participants received either an initial loading dose of trastuzumab 4 milligrams per kilogram (mg/kg), intravenously (IV), on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Trastuzumab Monotherapy
Trastuzumab, Taxane

Full analysis set (FAS) included all enrolled participants who received at least one dose of either trastuzumab or taxane.

Arm/Group Information

ID	Title	Description
BG000	Trastuzumab Monotherapy	Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
BG001	Trastuzumab, Taxane	Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator's discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Median

Full Range

years

Title

Denominators

Categories

Title	Measurements
	OG00161.0(48.7 to 80.4)

Secondary

Duration of Response - Percentage of Participants With Progressive Disease or Death

Duration of response was defined as the time from first confirmed CR or PR until death or progressive disease (PD). For TLs, PD was defined as at least a 20% increase in the SLD of the TL, taking as reference the smallest SLD recorded since the beginning of treatment or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of one or more new lesions or unequivocal progression of existing non target non-measurable lesions. Participants were censored at the date of the last tumor assessment.

FAS. Duration of response was assessed in participants with a best overall response of CR or PR. Cohort A (trastuzumab monotherapy) was closed prematurely due to enrollment difficulties. Therefore, Cohort A included only 3 participants and none of the data from these 3 participants were analyzed for any of the specified endpoints.

Posted

Number

percentage of participants

BL, Day 1 of Weeks 7, 13, 19, 25, 37, and 52, at the last administration of study treatment, every 24 weeks thereafter until disease progression for up to 6 months after the last participant was recruited

ID	Title	Description
OG000	Trastuzumab Monotherapy	Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
OG001	Trastuzumab, Taxane

Secondary

Duration of Response

The time, in months, from when the response (CR or PR) was first noted until the date of documented PD, death, or withdrawal, whichever occurred first. Participants were censored at the date of the last tumor assessment.

Posted

Median

95% Confidence Interval

months

ID	Title	Description
OG000	Trastuzumab Monotherapy	Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
OG001	Trastuzumab, Taxane	Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator's discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.

Secondary

Progression-free Survival (PFS) - Percentage of Participants With Progressive Disease

PFS was defined as the time from day of first study drug infusion until death or PD. Participants were censored at the date of the last tumor assessment.

Posted

Number

percentage of participants

ID	Title	Description
OG000	Trastuzumab Monotherapy	Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
OG001	Trastuzumab, Taxane	Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator's discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.

Secondary

Progression-Free Survival

The time, in months, from BL to PFS event.

Posted

Median

95% Confidence Interval

months

ID	Title	Description
OG000	Trastuzumab Monotherapy	Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
OG001	Trastuzumab, Taxane	Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator's discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.

Secondary

Percentage of Participants With Treatment Failure

Treatment failure was defined as the time from first study drug infusion to failure. Failure was defined as any of the following: PD, death, withdrawal due to adverse event (AE) or lab abnormality, or refusal of treatment. Participants were censored at the last date recorded in the case report form (CRF) or the date of withdrawal.

Posted

Number

percentage of participants

ID	Title	Description
OG000	Trastuzumab Monotherapy	Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
OG001	Trastuzumab, Taxane	Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator's discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.

Secondary

Time to Treatment Failure

The time, in months, from BL to treatment failure.

Posted

Median

95% Confidence Interval

months

ID	Title	Description
OG000	Trastuzumab Monotherapy	Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
OG001	Trastuzumab, Taxane	Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator's discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.

Secondary

Percentage of Participants With Clinical Benefit According to RECIST Guidelines

Clinical benefit was defined as stable disease (SD) for 6 months or longer, or a confirmed overall response of CR or PR. For TLs, SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since the beginning of treatment. For NTLs, SD was synonymous with incomplete response and defined as the persistence of one or more NTLs and/or maintenance of tumor marker level above the normal limits.

Posted

Number

95% Confidence Interval

percentage of participants

ID	Title	Description
OG000	Trastuzumab Monotherapy	Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
OG001	Trastuzumab, Taxane	Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator's discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.

Secondary

Overall Survival - Percentage of Participants Who Died

OS was defined as the time from the date of enrollment to the date of death due to any cause. Participants were censored at the last date recorded in the CRF.

Posted

Number

percentage of participants

BL, Day 1 of Weeks 1, 4, 7, 10, 13, 16, 19, 25, 37, and 5 at the last administration of study treatment, every 24 weeks thereafter until disease progression or death, yearly thereafter up to 2 years after cessation of recruitment

ID	Title	Description
OG000	Trastuzumab Monotherapy	Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
OG001	Trastuzumab, Taxane	Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator's discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.

Secondary

Overall Survival

The time, in months, from BL to death due to any cause.

Posted

Median

95% Confidence Interval

months

BL, Day 1 of Weeks 1, 4, 7, 10, 13, 16, 19, 25, 37, and 52 at the last administration of study treatment, every 24 weeks thereafter until disease progression or death, yearly thereafter up to 2 years after cessation of recruitment

ID	Title	Description
OG000	Trastuzumab Monotherapy	Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
OG001	Trastuzumab, Taxane	Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator's discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Trastuzumab Monotherapy	Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.			0	3	3	3
EG001	Trastuzumab, Taxane	Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator's discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.			6	41	36	41

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Bacterial Infection	Infections and infestations	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected3 at risk EG0011 affected41 at risk
Bronchitis	Infections and infestations	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected3 at risk EG0011 affected41 at risk
Sepsis	Infections and infestations	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected3 at risk EG0011 affected41 at risk
Febrile Neutropenia	Blood and lymphatic system disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected3 at risk EG0011 affected41 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected3 at risk EG0011 affected41 at risk
Sudden Death	General disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected3 at risk EG0011 affected41 at risk
Lymphoedema	Vascular disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected3 at risk EG0011 affected41 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Neutropenia	Blood and lymphatic system disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected3 at risk EG0015 affected41 at risk
Lacrimation increased	Eye disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected3 at risk EG0014 affected41 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected3 at risk EG0014 affected41 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected3 at risk EG00113 affected41 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected3 at risk EG0013 affected41 at risk
Nausea	Gastrointestinal disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected3 at risk EG0016 affected41 at risk
Stomatitis	Gastrointestinal disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected3 at risk EG0014 affected41 at risk
Vomiting	Gastrointestinal disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected3 at risk EG0015 affected41 at risk
Asthenia	General disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected3 at risk EG0016 affected41 at risk
Fatigue	General disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected3 at risk EG00110 affected41 at risk
Oedema peripheral	General disorders	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected3 at risk EG0017 affected41 at risk
Pyrexia	General disorders	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected3 at risk EG0016 affected41 at risk
Bronchitis	Infections and infestations	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected3 at risk EG0014 affected41 at risk
Nasopharyngitis	Infections and infestations	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected3 at risk EG0013 affected41 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected3 at risk EG0014 affected41 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected3 at risk EG0014 affected41 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected3 at risk EG0013 affected41 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected3 at risk EG0016 affected41 at risk
Headache	Nervous system disorders	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected3 at risk EG0013 affected41 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected3 at risk EG0013 affected41 at risk
Paraesthesia	Nervous system disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected3 at risk EG0014 affected41 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected3 at risk EG0015 affected41 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected3 at risk EG0014 affected41 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected3 at risk EG00113 affected41 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected3 at risk EG0013 affected41 at risk
Nail disorder	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected3 at risk EG0017 affected41 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected3 at risk EG0016 affected41 at risk
Urinary tract infection	Infections and infestations	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected3 at risk EG0010 affected41 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected3 at risk EG0010 affected41 at risk

Cohort A (trastuzumab monotherapy) was closed prematurely due to enrollment difficulties. Therefore, Cohort A included only 3 participants.

Certain Agreements

ID	Term
D001943	Breast Neoplasms

ID	Term
D000068878	Trastuzumab
C080625	taxane
D000077143	Docetaxel
D017239	Paclitaxel

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes

Facility	Status	City	State	ZIP	Country	Contacts
		Geelong	Victoria	3220	Australia

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases