A Study to Evaluate the Efficacy and Safety of Trastuzuma... | NCT02144012

NCT02144012

Status Module

Sponsor/Collaborators Module

Oversight Module

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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
Arm A: Trastuzumab emtansine	Experimental	Participants will be administered trastuzumab emtansine once every three weeks (Q3W). Participants may remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.	Drug: Trastuzumab Emtansine
Arm B: Trastuzumab + Docetaxel	Active Comparator	Participants will be administered trastuzumab plus docetaxel Q3W. Participants may remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.	Drug: Trastuzumab Drug: Docetaxel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Trastuzumab	Drug	For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.	Arm B: Trastuzumab + Docetaxel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-Free Survival (PFS)	PFS was defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurred first, on the basis of investigator assessments. Progression was defined according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 millimeter (mm) or the appearance of one or more new lesions.	At time of clinical data cut-off (up to 20 months)
Safety: Percentage of Participants With Adverse Events (AEs)	An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.	At time of clinical data cut-off (up to 20 months)
Safety: Percentage of Participants With Grade 3 and 4 AEs	Grade 3 and 4 AEs were evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0. Grade 3 was defined as severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living, including bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden. Grade 4 was defined as life-threatening consequences; urgent intervention indicated.	At time of clinical data cut-off (up to 20 months)
Percentage of Participants With Adverse Events Leading to Treatment Discontinuation		At time of clinical data cut-off (up to 20 months)

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival (OS)	OS was defined as the time from the date of randomization to the date of death from any cause.	At time of clinical data cut-off (up to 20 months)
One-Year Survival Rate

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age >/= 18 years
HER2-positive disease, as defined by an immunohistochemistry test score of 3+ and/or in situ hybridization positivity, prospectively confirmed by a Sponsor-designated central laboratory prior to enrollment
Histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease appropriate for chemotherapy
Patients must have measurable and/or non-measurable disease that is evaluable per the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Adequate organ function
For women of childbearing potential and men with partners of childbearing potential, agreement by the patient and/or partner to use two adequate non-hormonal forms of contraception during treatment and for at least 6 months after the last dose of study drug

Exclusion Criteria:

Pregnancy or lactation
Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease; wound healing disorders; ulcers; bone fractures, except bone fractures because of disease under study)
Currently known active infection with HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV)
Major surgical procedure or significant traumatic injury within approximately 28 days prior to randomization or anticipation of the need for major surgery during the course of study treatment
Current peripheral neuropathy Grade >/= 2 per National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE, v4.0)
History of systemic anti-cancer therapy after the diagnosis of metastatic breast cancer (MBC) or for recurrent locally advanced disease, with the exception of prior hormonal regimens for recurrent locally advanced disease or MBC
An interval of < 12 months after the last dose of vinca alkaloid or taxane chemotherapy (i.e., for treatment of early stage, non-metastatic disease)
Hormonal therapy < 7 days prior to randomization
Trastuzumab < 21 days prior to randomization
Lapatinib </= 14 days prior to randomization
Prior trastuzumab emtansine therapy
Treatment with any other anti-cancer therapy/investigational drug (not defined above) within 21 days prior to randomization
History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other malignancies with an expected curative outcome
Current chronic daily treatment with corticosteroids (dose > 10 mg/day methylprednisone equivalent)
History of intolerance (including Grade 3 or 4 infusion reaction) or hypersensitivity to trastuzumab, murine proteins, docetaxel or paclitaxel
Known hypersensitivity any of the study drugs, including excipients, or any drugs formulated in polysorbate 80

Contacts/Locations Module

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

References Module

No data available

No data is available for this block.

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	Arm A: Trastuzumab Emtansine	Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first. Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W.

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

One-year survival rate as determined by Kaplan-Meier estimates.

The intention-to-treat (ITT) population included all randomized participants grouped according to the treatment assigned at randomization.

Arm/Group Information

ID	Title	Description
BG000	Arm A: Trastuzumab Emtansine	Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first. Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W.
BG001	Arm B: Trastuzumab + Docetaxel	Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first. Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W. Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00034 BG00115 BG00249

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG00010.3(4.2 to NA)Not Available (NA) = parameter not estimable due to small number of participants included in analysis OG0018.2(6.0 to 13.8)

Primary

Safety: Percentage of Participants With Adverse Events (AEs)

An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

The safety analysis population consisted of all participants who received at least one dose of study drug. Safety analyses were based on the treatment that participants actually received.

Posted

Number

percentage of participants

At time of clinical data cut-off (up to 20 months)

ID	Title	Description
OG000	Arm A: Trastuzumab Emtansine	Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first. Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W.
OG001	Arm B: Trastuzumab + Docetaxel	Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first. Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W. Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W.

Primary

Safety: Percentage of Participants With Grade 3 and 4 AEs

Grade 3 and 4 AEs were evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0. Grade 3 was defined as severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living, including bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden. Grade 4 was defined as life-threatening consequences; urgent intervention indicated.

The safety analysis population consisted of all participants who received at least one dose of study drug. Safety analyses were based on the treatment that participants actually received.

Posted

Number

percentage of participants

At time of clinical data cut-off (up to 20 months)

ID	Title	Description
OG000	Arm A: Trastuzumab Emtansine	Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first. Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W.
OG001	Arm B: Trastuzumab + Docetaxel	Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first. Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W. Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W.

Primary

Percentage of Participants With Adverse Events Leading to Treatment Discontinuation

The safety analysis population consisted of all participants who received at least one dose of study drug. Safety analyses were based on the treatment that participants actually received.

Posted

Number

percentage of participants

At time of clinical data cut-off (up to 20 months)

ID	Title	Description
OG000	Arm A: Trastuzumab Emtansine	Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first. Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W.
OG001	Arm B: Trastuzumab + Docetaxel	Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first. Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W. Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W.

Primary

Safety: Percentage of Participants With Adverse Events Leading to Treatment Interruption

The safety analysis population consisted of all participants who received at least one dose of study drug. Safety analyses were based on the treatment that participants actually received.

Posted

Number

percentage of participants

At time of clinical data cut-off (up to 20 months)

ID	Title	Description
OG000	Arm A: Trastuzumab Emtansine	Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first. Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W.
OG001	Arm B: Trastuzumab + Docetaxel	Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first. Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W. Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W.

Primary

Safety: Percentage of Participants With Adverse Events Leading to Dose Reduction

The safety analysis population consisted of all participants who received at least one dose of study drug. Safety analyses were based on the treatment that participants actually received.

Posted

Number

percentage of participants

At time of clinical data cut-off (up to 20 months)

ID	Title	Description
OG000	Arm A: Trastuzumab Emtansine	Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first. Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W.
OG001	Arm B: Trastuzumab + Docetaxel	Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first. Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W. Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W.

Primary

Safety: Percentage of Participants With Significant Decline in Left Ventricular Ejection Fraction (LVEF)

Significant decline in LVEF was defined as LVEF below 50% and decrease from baseline of 15% points or more. Echocardiogram or multiple-gated acquisition (MUGA) scan was used to assess LVEF.

The safety analysis population consisted of all participants who received at least one dose of study drug. Safety analyses were based on the treatment that participants actually received.

Posted

Number

percentage of participants

At time of clinical data cut-off (up to 20 months)

ID	Title	Description
OG000	Arm A: Trastuzumab Emtansine	Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first. Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W.
OG001	Arm B: Trastuzumab + Docetaxel	Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first. Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W. Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W.

Secondary

Overall Survival (OS)

OS was defined as the time from the date of randomization to the date of death from any cause.

The ITT population included all randomized participants grouped according to the treatment assigned at randomization.

Posted

Median

95% Confidence Interval

months

At time of clinical data cut-off (up to 20 months)

ID	Title	Description
OG000	Arm A: Trastuzumab Emtansine	Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first. Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W.
OG001	Arm B: Trastuzumab + Docetaxel	Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first. Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W. Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W.

Secondary

One-Year Survival Rate

One-year survival rate as determined by Kaplan-Meier estimates.

The ITT population included all randomized participants grouped according to the treatment assigned at randomization. Participants, for whom data were collected, are included in the analysis for this outcome measure.

Posted

Median

95% Confidence Interval

percentage of participants

At 12 months

ID	Title	Description
OG000	Arm A: Trastuzumab Emtansine	Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first. Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W.
OG001	Arm B: Trastuzumab + Docetaxel	Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first. Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W. Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W.

Secondary

OS Truncated at 2 Years

OS truncated at 2 years was defined as the time from the date of randomization to the date of death from any cause, with deaths occurring beyond 2 years after the participant's randomization date censored at 2 years.

Data for this outcome measure were not collected and are therefore not reported. The study was terminated before the time point for data collection of this outcome measure.

Posted

At 24 months

ID	Title	Description
OG000	Arm A: Trastuzumab Emtansine	Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first. Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W.
OG001	Arm B: Trastuzumab + Docetaxel	Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first. Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W. Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W.

Secondary

Objective Response Rate (ORR)

ORR was defined as percentage of participants with partial response (PR) or complete response (CR) determined on the basis of investigator assessments with the use of RECIST v1.1. Tumor assessments were performed with computed tomography (CT) or magnetic resonance imaging (MRI) scans of the chest, abdomen, and pelvis. CR: disappearance of all target lesions; PR: >=30% decrease in the sum of the longest diameter of target lesions; Objective Response Rate (OR) = CR + PR.

Posted

Number

95% Confidence Interval

percentage of participants

At time of clinical data cut-off (up to 20 months)

ID	Title	Description
OG000	Arm A: Trastuzumab Emtansine	Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first. Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W.
OG001	Arm B: Trastuzumab + Docetaxel	Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first. Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W. Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W.

Secondary

Duration of Response (DOR)

DOR was defined as the time from the date of initial confirmed PR or CR to the date of disease progression or death within the study. CR: disappearance of all target lesions; PR: >=30% decrease in the sum of the longest diameter of target lesions. Disease progression was defined according to RECIST, v1.1 as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions.

Posted

Median

95% Confidence Interval

months

At time of clinical data cut-off (up to 20 months)

ID	Title	Description
OG000	Arm A: Trastuzumab Emtansine	Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first. Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W.
OG001	Arm B: Trastuzumab + Docetaxel	Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first. Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W. Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W.

Secondary

Pharmacokinetics: Serum Concentrations of Study Medications

Pharmacokinetic (PK) parameters were to be determined in a subset of participants. PK samples from the first 100 Chinese participants were planned to be collected.

No PK analyses were performed as no participants were enrolled from China and no samples were collected.

Posted

Day 1, Cycle 1 (Day 1), Day 1, Cycle 2 (Day 22), Day 1, Cycle 4 (Day 64) and at study drug completion or discontinuation visit (up to 20 months)

ID	Title	Description
OG000	Arm A: Trastuzumab Emtansine	Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first. Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W.
OG001	Arm B: Trastuzumab + Docetaxel	Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first. Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W. Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W.

Secondary

Immunogenicity: Percentage of Positive Anti-Therapeutic Antibody (ATA) Response to Trastuzumab Emtansine

The ITT population included all randomized participants grouped according to the treatment assigned at randomization. Only participants with at least one post-dose sample available for ATA analysis were analyzed for this outcome measure.

Posted

Number

percentage of participants

Day 1, Cycle 1 (Day 1), Day 1, Cycle 4 (Day 64) and at study drug completion or discontinuation visit (up to 20 months)

ID	Title	Description
OG000	Arm A: Trastuzumab Emtansine	Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first. Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W.

Units	Counts
Participants	OG000

Secondary

Patient-Reported Outcomes: Number of Participants Who Completed the Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Questionnaire

The FACT-B (version 4) is a self-reported instrument which measures health-related quality of life (HRQOL) of participants with breast cancer.The FACT-B includes the breast cancer sub-scale (BCS) and is comprised of nine items specific to assessing patients' HRQOL in breast cancer.

The ITT population included all randomized participants grouped according to the treatment assigned at randomization.

Posted

Count of Participants

Participants

On the first Day of each 21-day Cycle (Day 1, 22, 43, etc.) and at study drug completion or discontinuation visit (up to 20 months)

ID	Title	Description
OG000	Arm A: Trastuzumab Emtansine	Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first. Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W.
OG001	Arm B: Trastuzumab + Docetaxel	Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first. Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W. Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W.

Secondary

Patient-Reported Outcomes: Number of Participants Who Completed the FACT-Taxane Questionnaire

The FACT - Taxane is a self-reported instrument which measures the HRQOL of participants receiving taxane containing chemotherapy. The FACT-Taxane consists of 16 items and was designed to assess the impact of taxane treatment-related symptoms from the participant's perspective.

The ITT population included all randomized participants grouped according to the treatment assigned at randomization.

Posted

Count of Participants

Participants

Days 1 and 8 of Cycles 1 and 2 and on the first day of each subsequent 21-day cycle thereafter as well as at study drug completion or discontinuation visit (up to 20 months)

ID	Title	Description
OG000	Arm A: Trastuzumab Emtansine	Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first. Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W.
OG001	Arm B: Trastuzumab + Docetaxel	Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first. Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W. Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W.

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	Arm A: Trastuzumab Emtansine	Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first. Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W.			8	34	31	34
EG001	Arm B: Trastuzumab + Docetaxel	Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first. Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W. Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W.			5	15	15	15

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected34 at risk EG0013 affected15 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected34 at risk EG0012 affected15 at risk
Pneumonia	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0002 affected34 at risk EG0011 affected15 at risk
Post procedural cellulitis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0000 affected34 at risk EG0011 affected15 at risk
Pyrexia	General disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected34 at risk EG0010 affected15 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected34 at risk EG0010 affected15 at risk
Hyperammonaemia	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected34 at risk EG0010 affected15 at risk
Normal pressure hydrocephalus	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected34 at risk EG0011 affected15 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected34 at risk EG0010 affected15 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected34 at risk EG0010 affected15 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected34 at risk EG0014 affected15 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected34 at risk EG0016 affected15 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (18.1)	Systematic Assessment	EG0007 affected34 at risk EG0010 affected15 at risk
Pericardial effusion	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected34 at risk EG0011 affected15 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected34 at risk EG0011 affected15 at risk
Lacrimation decreased	Eye disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected34 at risk EG0011 affected15 at risk
Vision blurred	Eye disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected34 at risk EG0011 affected15 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0005 affected34 at risk EG0010 affected15 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected34 at risk EG0014 affected15 at risk
Constipation	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected34 at risk EG0011 affected15 at risk
Dental caries	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected34 at risk EG0011 affected15 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0007 affected34 at risk EG00111 affected15 at risk
Dry mouth	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected34 at risk EG0010 affected15 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected34 at risk EG0012 affected15 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected34 at risk EG0011 affected15 at risk
Nausea	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG00011 affected34 at risk EG0013 affected15 at risk
Stomatitis	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected34 at risk EG0012 affected15 at risk
Vomiting	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected34 at risk EG0015 affected15 at risk
Asthenia	General disorders	MedDRA (18.1)	Systematic Assessment	EG0004 affected34 at risk EG0011 affected15 at risk
Catheter site pain	General disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected34 at risk EG0011 affected15 at risk
Chest discomfort	General disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected34 at risk EG0010 affected15 at risk
Chills	General disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected34 at risk EG0010 affected15 at risk
Device occlusion	General disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected34 at risk EG0011 affected15 at risk
Extravasation	General disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected34 at risk EG0011 affected15 at risk
Face oedema	General disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected34 at risk EG0011 affected15 at risk
Fatigue	General disorders	MedDRA (18.1)	Systematic Assessment	EG0009 affected34 at risk EG0011 affected15 at risk
Feeling cold	General disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected34 at risk EG0011 affected15 at risk
Generalised oedema	General disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected34 at risk EG0014 affected15 at risk
Malaise	General disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected34 at risk EG0012 affected15 at risk
Mucosal inflammation	General disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected34 at risk EG0012 affected15 at risk
Oedema peripheral	General disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected34 at risk EG0015 affected15 at risk
Pain	General disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected34 at risk EG0012 affected15 at risk
Pyrexia	General disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected34 at risk EG0013 affected15 at risk
Central nervous system infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0000 affected34 at risk EG0011 affected15 at risk
Groin infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0000 affected34 at risk EG0011 affected15 at risk
Herpes zoster	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0000 affected34 at risk EG0012 affected15 at risk
Laryngitis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0000 affected34 at risk EG0011 affected15 at risk
Nasopharyngitis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0000 affected34 at risk EG0011 affected15 at risk
Otitis media	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0000 affected34 at risk EG0011 affected15 at risk
Paronychia	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0000 affected34 at risk EG0011 affected15 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG00013 affected34 at risk EG0014 affected15 at risk
Urinary tract infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0002 affected34 at risk EG0011 affected15 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0003 affected34 at risk EG0010 affected15 at risk
Seroma	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0000 affected34 at risk EG0011 affected15 at risk
Alanine aminotransferase increased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0006 affected34 at risk EG0010 affected15 at risk
Aspartate aminotransferase increased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0008 affected34 at risk EG0011 affected15 at risk
Blood cholesterol increased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0001 affected34 at risk EG0011 affected15 at risk
Platelet count decreased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0003 affected34 at risk EG0010 affected15 at risk
Weight increased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0001 affected34 at risk EG0014 affected15 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0006 affected34 at risk EG0011 affected15 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected34 at risk EG0011 affected15 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected34 at risk EG0011 affected15 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected34 at risk EG0010 affected15 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected34 at risk EG0011 affected15 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected34 at risk EG0011 affected15 at risk
Limb discomfort	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected34 at risk EG0011 affected15 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected34 at risk EG0010 affected15 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected34 at risk EG0011 affected15 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected34 at risk EG0010 affected15 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG00011 affected34 at risk EG0018 affected15 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected34 at risk EG0010 affected15 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected34 at risk EG0011 affected15 at risk
Dizziness	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected34 at risk EG0014 affected15 at risk
Headache	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG00011 affected34 at risk EG0015 affected15 at risk
Hypoaesthesia	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected34 at risk EG0011 affected15 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected34 at risk EG0012 affected15 at risk
Paraesthesia	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected34 at risk EG0011 affected15 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0008 affected34 at risk EG0018 affected15 at risk
Hallucination, auditory	Psychiatric disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected34 at risk EG0011 affected15 at risk
Insomnia	Psychiatric disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected34 at risk EG0013 affected15 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected34 at risk EG0011 affected15 at risk
Breast discharge	Reproductive system and breast disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected34 at risk EG0010 affected15 at risk
Breast pain	Reproductive system and breast disorders	MedDRA (18.1)	Systematic Assessment	EG0005 affected34 at risk EG0010 affected15 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG00010 affected34 at risk EG0010 affected15 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected34 at risk EG0013 affected15 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected34 at risk EG0011 affected15 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0004 affected34 at risk EG0010 affected15 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected34 at risk EG0011 affected15 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected34 at risk EG0011 affected15 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected34 at risk EG0010 affected15 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected34 at risk EG0010 affected15 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected34 at risk EG0011 affected15 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected34 at risk EG00110 affected15 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected34 at risk EG0011 affected15 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected34 at risk EG0012 affected15 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected34 at risk EG0011 affected15 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected34 at risk EG0011 affected15 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected34 at risk EG0010 affected15 at risk
Hyperkeratosis	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected34 at risk EG0011 affected15 at risk
Nail discolouration	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected34 at risk EG0012 affected15 at risk
Nail disorder	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected34 at risk EG0013 affected15 at risk
Nail ridging	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected34 at risk EG0011 affected15 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected34 at risk EG0011 affected15 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected34 at risk EG0010 affected15 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected34 at risk EG0013 affected15 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected34 at risk EG0011 affected15 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected34 at risk EG0010 affected15 at risk
Hypertension	Vascular disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected34 at risk EG0011 affected15 at risk

Due to early termination of the study only limited data from a small subset (49) of the originally planned study population size (561) are available and were too limited to perform originally planned efficacy analyses as specified in the protocol.

Certain Agreements

ID	Term
D001943	Breast Neoplasms

ID	Term
D000068878	Trastuzumab
D000080044	Ado-Trastuzumab Emtansine
D000077143	Docetaxel

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
D008453	Maytansine
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals
D047029	Lactams, Macrocyclic
D047028	Macrocyclic Compounds
D011083	Polycyclic Compounds
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D004224	Diterpenes
D013729	Terpenes

Units	Counts
Participants	OG00034 OG00115

Units	Counts
Participants	OG00034 OG00115

Units	Counts
Participants	OG00034 OG00115

Units	Counts
Participants	OG00034 OG00115

Facility	Status	City	State	ZIP	Country	Contacts
		Sabah	Sabah	88996	Malaysia

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