T-DM1 vs Paclitaxel/Trastuzumab for Breast (ATEMPT Trial)

Breast Cancer Clinical Trial

Official title:

A Randomized Phase II Study of Trastuzumab Emtansine (T-DM1) vs. Paclitaxel in Combination With Trastuzumab for Stage I HER2-Positive Breast Cancer (ATEMPT Trial)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01853748
• Other study ID #: 13-048
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: May 2013
• Est. completion date: May 2024

Study information

• Verified date: January 2024
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it-such as the safest dose to use, the side effects it may cause, and if the drug is effective for treating different types of cancer. It also means that the FDA has not approved this drug for use patients undergoing adjuvant treatment for HER2+ breast cancer. Trastuzumab emtansine (T-DM1) is a drug that may stop cancer cells from growing. This drug has been used in other research studies and information from those other research studies suggests that this drug may help to prevent the recurrence of breast cancer in this research study.

The use of T-DM1 in this research study is experimental, which means it is not approved by any regulatory authority for the adjuvant treatment of HER2-positive breast cancer. However, it FDA-approved for metastatic HER2-positive breast cancer. T-DM1 has caused cancer cells to die in laboratory studies. In preclinical studies, this drug has prevented or slowed the growth of breast cancer. The breast cancer treatments (paclitaxel and Trastuzumab) used in this study are considered part of standard-of-care regimens in early breast cancer. A standard treatment means that this is a treatment that would be accepted by the majority of the medical community as a suitable treatment for your type of breast cancer.

In this research study, the investigators are looking to see if the study drug T-DM1 will have less side effects than traditional HER2-positive breast cancer treatment of trastuzumab and paclitaxel. The investigators are also hoping to learn about the long term benefits and disease-free survival of participants who take the study drug T-DM1 in comparison to those participants to take the combination of trastuzumab and paclitaxel.

Description:

If a participant agrees to participate in this study she will be asked to undergo some screening tests or procedures to confirm that she is eligible. Many of these tests and procedures are likely to be part of regular cancer care and may be done even if turns out that she does not take part in this research study. If she has had some of these tests or procedures recently, they may or may not have to be repeated. These tests and procedures will include: a medical history, performance status, assessment of your tumor, blood tests, cardiac tests, pregnancy test and a collection of tumor tissue. If these tests show that she is eligible to participate in the research study, she will begin the study treatment. If she does not meet the eligibility criteria, she will not be able to participate in this research study.

Because no one knows which of the study options is best, the participant will be "randomized" into one of the study groups after she has had her breast surgery: Group 1 or Group 2. Randomization means that she is put into a group by chance. Neither the participant nor the research doctor will choose what group she will be in. The participant will have a one in three chance of being placed in any group. Approximately 375 study participants will receive the study drug, while 125 study participants will receive the standard therapy of trastuzumab and paclitaxel.

Group 1 participants will receive the study drug T-DM1 every three weeks by IV (intravenous injection) for 17 treatments (total of 51 weeks).

Group 2 participants will receive the FDA-approved drugs Paclitaxel and Trastuzumab once per week by IV for 12 weeks. Then beginning week 13, participants will receive Trastuzumab only by IV injection every three weeks for the next 13 treatments.

During all cycles the participant will have a physical exam and tumor assessment.

The investigators would like to keep track of the participant's medical condition for the next five years after the final dose of study drug. The investigators would like to do this by regular visits every 6 months for 3 years after completion of study treatment, and then once a year for the next two years. The investigators may ask for additional follow-up by phone after completion of these visits.

Participants who undergo lumpectomy (breast conserving surgery) need to receive breast radiation therapy to participate in this study. Participants who have undergone a mastectomy may receive chest wall and lymph node radiation (as determined by discussion with their physician). Radiation Therapy will begin after the conclusion of all study paclitaxel doses, and after 12 weeks fo the study drug T-DM1.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 512
• Est. completion date: May 2024
• Est. primary completion date: August 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• HER2-positive Stage I histologically confirmed invasive carcinoma of the breast

• ER/PR determination is required

• HER2 positive, confirmed by central testing: IHC 3+, FISH HER2/CEP17 <2.0 with an average HER2 copy number >/=6.0, or FISH HER2/CEP17 >/= 2.0

• Bilateral breast cancers that individually meet eligibility criteria are allowed

• Subjects with multifocal or multicentric disease are eligible as long as each tumor individually meets eligibility criteria

• Subjects with a history of ipsilateral DCIS are eligible if they were treated with wide-excision alone, without radiation therapy; Patients with a history of contralateral DCIS are not eligible.

• Should have tumor tissue available and a tissue block of sufficient size to make 15 slides, which must be sent to a DFCI site for testing

• Less than or equal to 90 days since most recent breast surgery for this breast cancer

• All tumor should be removed by either a modified radical mastectomy or a segmental mastectomy (lumpectomy) with either a sentinel node biopsy or axillary dissection

• All margins should be clear of invasive cancer or DCIS

• May have received up to 4 weeks of tamoxifen therapy or other hormonal therapy, for adjuvant therapy for this cancer

• Prior oophorectomy for cancer prevention is allowed

• Subjects who have undergone partial breast radiation (duration </= 7 days) prior to registration are eligible. Partial breast radiation must be completed prior to 2 weeks before starting protocol therapy.

• Must have discontinued any investigational drug at least 2 weeks prior to participation

• Willing to use one highly effective from of nonhormonal contraception or two effective forms of nonhormonal contraception while on study and for 7 months after end of study treatment

• Subjects undergoing lumpectomy must have no contraindications to radiation therapy

Exclusion Criteria:

• Pregnant or breastfeeding

• Use of potent CYP3A4 inhibitors during the study treatment period

• Excessive alcohol intake (more than 3 alcoholic beverages per day)

• Locally advanced tumors at diagnosis

• History of previous invasive breast cancer

• History of prior chemotherapy in the past 5 years

• History of prior trastuzumab or prior paclitaxel therapy

• Active, unresolved infection

• Active liver disease

• History of a different malignancy except for the following: disease free for at least 5 years and at low risk for recurrence; cervical cancer in situ, basal or squamous cell carcinoma of the skin

• Active cardiac disease

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Trastuzumab

• Paclitaxel

• Trastuzumab emtansine

Locations

Country	Name	City	State
United States	Lehigh Valley Hospital/Lehigh Valley Health Network	Allentown	Pennsylvania
United States	Univeristy of Michigan Health System	Ann Arbor	Michigan
United States	Johns Hopkins - Sidney Kimmel Comprehensive Cancer Center	Baltimore	Maryland
United States	Memorial Sloan Kettering Cancer Center-Basking Ridge	Basking Ridge	New Jersey
United States	UPMC/HVHS Cancer Center, UPMC Beaver	Beaver	Pennsylvania
United States	Suburban Hospital Cancer Program	Bethesda	Maryland
United States	University of Alabama Birmingham	Birmingham	Alabama
United States	Mountain States Tumor Institute	Boise	Idaho
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana Farber Cancer Institute at Faulkner Hospital	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Eastern Maine Medical Center's Cancer Care	Brewer	Maine
United States	UPMC CancerCenters Butler	Butler	Pennsylvania
United States	University of North Carolina	Chapel Hill	North Carolina
United States	The Ohio State University	Columbus	Ohio
United States	Memorial Sloan Kettering Cancer Center-Suffolk	Commack	New York
United States	New Hampshire Oncology-Hematology, PA	Concord	New Hampshire
United States	Mass General North Shore Cancer Center	Danvers	Massachusetts
United States	Duke University Medical Center	Durham	North Carolina
United States	UPMC Horizon (Shenango)	Farrell	Pennsylvania
United States	Florida Cancer Specialists	Fort Myers	Florida
United States	Mountain States Tumor Institute	Fruitland	Idaho
United States	Arnold Palmer Cancer Center-Greensburg	Greensburg	Pennsylvania
United States	Arnold Palmer Medical Oncology Oakbrook	Greensburg	Pennsylvania
United States	UPMC Horizon (Greenville)	Greenville	Pennsylvania
United States	UPMC Pinnacle Harrisburg	Harrisburg	Pennsylvania
United States	Memorial Sloan Kettering Cancer Center Westchester	Harrison	New York
United States	Hartford Hospital	Hartford	Connecticut
United States	New Hampshire Oncology-Hematology, PA	Hooksett	New Hampshire
United States	Baylor College of Medicine-Baylor Clinic	Houston	Texas
United States	Harris County Hospital District-Ben Taub General Hospital	Houston	Texas
United States	Harris County Hospital District-Smith Clinic	Houston	Texas
United States	MD Anderson Cancer Center	Houston	Texas
United States	Indiana University - Springmill Medical Clinic	Indianapolis	Indiana
United States	Indiana University - Wishard Hospital	Indianapolis	Indiana
United States	Indiana University Health - Melvin and Bren Simon Cancer Center	Indianapolis	Indiana
United States	Indiana University Health - University Hospital	Indianapolis	Indiana
United States	Queens Hospital Center, Comprehensive Cancer Center	Jamaica	New York
United States	UPMC Cancer Center Jefferson Regional Med Ctr	Jefferson Hills	Pennsylvania
United States	UPMC Conemaugh Cancer Center	Johnstown	Pennsylvania
United States	New Hampshire Oncology-Hematology, PA	Laconia	New Hampshire
United States	Northwell Health/Monter Cancer Center	Lake Success	New York
United States	Dana-Farber Cancer Insitute at Londonderry Hospital	Londonderry	New Hampshire
United States	Lowell General Hospital	Lowell	Massachusetts
United States	Johns Hopkins - Green Spring Station	Lutherville	Maryland
United States	Loyola University Medical Center	Maywood	Illinois
United States	UPMC McKeesport	McKeesport	Pennsylvania
United States	Midstate Medical Center	Meriden	Connecticut
United States	Mountain States Tumor Institute	Meridian	Idaho
United States	Dana-Farber Cancer Institute at Milford Hospital	Milford	Massachusetts
United States	UPMC East	Monroeville	Pennsylvania
United States	Arnold Palmer Medical Oncology-Mt Pleasant	Mount Pleasant	Pennsylvania
United States	Mountain States Tumor Institute	Nampa	Idaho
United States	Tennessee Oncology/Sarah Cannon Research Institute	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Hartford Healthcare Cancer Institute at The Hospital of Central Connecticut	New Britain	Connecticut
United States	UPMC Jameson Cancer Center	New Castle	Pennsylvania
United States	University of Chicago Comprehensive Cancer Center at Silver Cross Hospital	New Lenox	Illinois
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	William W Backus Hospital	Norwich	Connecticut
United States	University of Chicago Medical Center for Advanced Care Orland Park	Orland Park	Illinois
United States	UPMC Cancer Center St. Clair Hospital	Pittsburgh	Pennsylvania
United States	UPMC Passavant	Pittsburgh	Pennsylvania
United States	UPMC Presbyterian Shadyside	Pittsburgh	Pennsylvania
United States	UPMC St. Margaret	Pittsburgh	Pennsylvania
United States	Rex Cancer Center	Raleigh	North Carolina
United States	Mayo Clinic	Rochester	Minnesota
United States	Memorial Sloan Kettering Cancer Center-Mercy	Rockville Centre	New York
United States	Barnes-Jewish Hospital	Saint Louis	Missouri
United States	Siteman Cancer Center - South County	Saint Louis	Missouri
United States	Siteman Cancer Center - West County	Saint Louis	Missouri
United States	Washington University, School of Medicine	Saint Louis	Missouri
United States	Siteman Cancer Center - St. Peters	Saint Peters	Missouri
United States	Florida Cancer Specialists	Saint Petersburg	Florida
United States	University of California San Francisco	San Francisco	California
United States	University of Washington Seattle Cancer Care Alliance	Seattle	Washington
United States	UPMC Northwest (Franklin)	Seneca	Pennsylvania
United States	UPMC Northwest (Oil City)	Seneca	Pennsylvania
United States	Memorial Sloan Kettering Cancer Center-Sleepy Hollow	Sleepy Hollow	New York
United States	Mountain States Tumor Institute	Twin Falls	Idaho
United States	Georgetown Hospital	Washington	District of Columbia
United States	Sibley Memorial Hospital	Washington	District of Columbia
United States	UPMC and the Washington Hospital Center	Washington	Pennsylvania
United States	Washington Cancer Institute at Medstar Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants of Clinically Relevant Toxicities (CRT)	Clinically relevant toxicities will include the composite incidence of grade 3 or higher non-hematologic toxicity, grade 2 or higher neurotoxicity, and grade 4 or higher hematologic toxicity. These toxicities will only be assessed at the pre-specified toxicity-assessment visits. In addition, the following events, regardless of timing of their occurrence, will also count towards the composite endpoint: febrile neutropenia, any toxicity requiring dose-delay, discontinuation of any study treatment (Paclitaxel, Trastuzumab, or T-DM1) for toxicity, and any serious adverse event (SAE).	5 years after completion of study treatment or until death, whichever occurs first.
Primary	3-year Disease Free Survival (DFS) Rate of Trastuzumab Emtansine (TDM-1)	Disease-free survival (DFS) is evaluated and defined per protocol: from the time of randomization until the to the occurrence of the first of the following events: Local/regional recurrence: a recurrent or new invasive ipsilateral breast cancer, invasive breast cancer in the axilla, regional lymph nodes, chest wall, or skin of the ipsilateral breast.; Contralateral invasive breast cancer,; Distant recurrence: metastatic disease that has either been biopsy confirmed or clinically diagnosed as recurrent invasive breast cancer. A single new lesion on a bone scan without evidence of lytic disease on x-ray and without symptoms does not in and of itself constitute distant recurrence, but multiple new bone lesions, or increased isotope uptake associated with new bone symptoms are more likely due to metastases. Bone metastases must be documented with x-rays and clinical description.; Death from any cause	3 years
Secondary	Incidence Rate of Grade 3-4 Treatment-Related Toxicity	All grade 3 - 4 adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv4 as reported on case report forms were counted. Incidence is the number of patients experiencing at least one treatment-related grade >=3 AE of any type during the time of observation.	AE is reported every 3 weeks for the first 12 weeks, then every 9 weeks for the subsequent 39 weeks, then follow-up up to 5 years after completion of study treatment or until death, whichever occurs first. Median follow-up 3.1 years.
Secondary	Quality of Life (QOL) FACT B Total Score at Baseline	The QOL assessments questionnaire should be completed via the tablet provided by the study or on any available computer with an internet connection. The FACT-B questionnaire consists of five subscale, listed below: Physical well being(PWB): range 0-28 Social/Family well being(SWB): range 0-28 Emotional well being(EWB): range 0-24 Functional well being(FWB): range 0-28 Breast cancer subscale(BCS): range 0-40 The total score (FACTB) is calculated by summarizing all the subscales listed above, therefore it ranges from 0 to 148. The higher the score the better the outcome (applies to all sub-scales as well).	at baseline
Secondary	Quality of Life (QOL) FACT B Total Score at Week 3	The QOL assessments questionnaire should be completed via the tablet provided by the study or on any available computer with an internet connection. The FACT-B questionnaire consists of five subscale, listed below: Physical well being(PWB): range 0-28 Social/Family well being(SWB): range 0-28 Emotional well being(EWB): range 0-24 Functional well being(FWB): range 0-28 Breast cancer subscale(BCS): range 0-40 The total score (FACTB) is calculated by summarizing all the subscales listed above, therefore it ranges from 0 to 148. The higher the score the better the outcome (applies to all sub-scales as well).	at week 3
Secondary	Quality of Life (QOL) FACT B Total Score at Week 12	The QOL assessments questionnaire should be completed via the tablet provided by the study or on any available computer with an internet connection. The FACT-B questionnaire consists of five subscale, listed below: Physical well being(PWB): range 0-28 Social/Family well being(SWB): range 0-28 Emotional well being(EWB): range 0-24 Functional well being(FWB): range 0-28 Breast cancer subscale(BCS): range 0-40 The total score (FACTB) is calculated by summarizing all the subscales listed above, therefore it ranges from 0 to 148. The higher the score the better the outcome (applies to all sub-scales as well).	at week 12
Secondary	Quality of Life (QOL) FACT B Total Score at 6 Months	The QOL assessments questionnaire should be completed via the tablet provided by the study or on any available computer with an internet connection. The FACT-B questionnaire consists of five subscale, listed below: Physical well being(PWB): range 0-28 Social/Family well being(SWB): range 0-28 Emotional well being(EWB): range 0-24 Functional well being(FWB): range 0-28 Breast cancer subscale(BCS): range 0-40 The total score (FACTB) is calculated by summarizing all the subscales listed above, therefore it ranges from 0 to 148. The higher the score the better the outcome (applies to all sub-scales as well).	at 6 months
Secondary	Quality of Life (QOL) FACT B Total Score at 1 Year	The QOL assessments questionnaire should be completed via the tablet provided by the study or on any available computer with an internet connection. The FACT-B questionnaire consists of five subscale, listed below: Physical well being(PWB): range 0-28 Social/Family well being(SWB): range 0-28 Emotional well being(EWB): range 0-24 Functional well being(FWB): range 0-28 Breast cancer subscale(BCS): range 0-40 The total score (FACTB) is calculated by summarizing all the subscales listed above, therefore it ranges from 0 to 148. The higher the score the better the outcome (applies to all sub-scales as well).	at 1 year
Secondary	Quality of Life (QOL) FACT B Total Score at 18 Months	The QOL assessments questionnaire should be completed via the tablet provided by the study or on any available computer with an internet connection. The FACT-B questionnaire consists of five subscale, listed below: Physical well being(PWB): range 0-28 Social/Family well being(SWB): range 0-28 Emotional well being(EWB): range 0-24 Functional well being(FWB): range 0-28 Breast cancer subscale(BCS): range 0-40 The total score (FACTB) is calculated by summarizing all the subscales listed above, therefore it ranges from 0 to 148. The higher the score the better the outcome (applies to all sub-scales as well).	at 18 months
Secondary	Quality of Life (QOL) FACT B Total Score at 24 Months	The QOL assessments questionnaire should be completed via the tablet provided by the study or on any available computer with an internet connection. The FACT-B questionnaire consists of five subscale, listed below: Physical well being(PWB): range 0-28 Social/Family well being(SWB): range 0-28 Emotional well being(EWB): range 0-24 Functional well being(FWB): range 0-28 Breast cancer subscale(BCS): range 0-40 The total score (FACTB) is calculated by summarizing all the subscales listed above, therefore it ranges from 0 to 148. The higher the score the better the outcome (applies to all sub-scales as well).	at 24 months
Secondary	Number of Patients Has Neuropathy	Neuropathy evaluated by Patient Neurotoxicity Questionnaire (PNQ) defined per protocol.	Surveys are took at week 3, 12 and month 6 and 12 during treatment, and month 18. The data cutoff date is 18 month.
Secondary	Percentage of Work Time Missed Because of Health	Effects of therapy on work productivity and activity - work time missed because of health, evaluated using the Work Productivity and Activity Impairment Questionnaire (WPAI-SHP), which defined per protocol.	Surveys are took at week 3, 12 and month 6 and 12 during treatment, and month 18, 24, 30 and 36 during follow up.
Secondary	Percentage of Impairment While Working Because of Health (Mean, SD)	Effects of therapy on work productivity and activity - Impairment While Working because of health, evaluated using the Work Productivity and Activity Impairment Questionnaire (WPAI-SHP), which defined per protocol.	Surveys are took at week 3, 12 and month 6 and 12 during treatment, and month 18, 24, 30 and 36 during follow up.
Secondary	Percentage of Overall Work Impairment Because of Health	Effects of therapy on work productivity and activity - Work Impairment because of health, evaluated using the Work Productivity and Activity Impairment Questionnaire (WPAI-SHP), which defined per protocol.	Surveys are took at week 3, 12 and month 6 and 12 during treatment, and month 18, 24, 30 and 36 during follow up.
Secondary	Percentage of Activity Impairment Because of Health	Effects of therapy on work productivity and activity - Activity Impairment because of health, evaluated using the Work Productivity and Activity Impairment Questionnaire (WPAI-SHP), which defined per protocol.	Surveys are took at week 3, 12 and month 6 and 12 during treatment, and month 18, 24, 30 and 36 during follow up.
Secondary	Number of Patients Have Alopecia	alopecia assessment is a 5-item questionnaire that will assess the impact alopecia has had on these patients and will be conducted electronically at pre-specified study visits. If electronic evaluation is not possible, paper evaluation will be conducted.	Median follow-up was 3.9 years. The AE data cutoff date is 21 April 2020.
Secondary	3-year T-DM1 iDFS Percentage by Tumor Size and Hormone Receptor (HR) Status	Disease-free survival (DFS) is evaluated in patients treated with trastuzumab emtansine, which is defined per protocol: from the time of randomization until the to the occurrence of the first of the following events: Local/regional recurrence: a recurrent or new invasive ipsilateral breast cancer, invasive breast cancer in the axilla, regional lymph nodes, chest wall, or skin of the ipsilateral breast.; Contralateral invasive breast cancer,; Distant recurrence: metastatic disease that has either been biopsy confirmed or clinically diagnosed as recurrent invasive breast cancer. A single new lesion on a bone scan without evidence of lytic disease on x-ray and without symptoms does not in and of itself constitute distant recurrence, but multiple new bone lesions, or increased isotope uptake associated with new bone symptoms are more likely due to metastases. Bone metastases must be documented with x-rays and clinical description.; Death from any cause	3 years
Secondary	Number of Incidence of Grade 3-4 Cardiac Left Ventricular Dysfunction	All grade 3 - 4 adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv4 as reported on case report forms were counted. Incidence is the number of patients experiencing at least one treatment-related grade >=3 AE of any type during the time of observation	AE is reported every 3 weeks for the first 12 weeks, then every 9 weeks for the subsequent 39 weeks, then follow-up up to 5 years after completion of study treatment or until death, whichever occurs first. Median follow-up 3.1 years.
Secondary	Number of Incidence of T-DM1 Induced Grade 2-3 Thrombocytopenia	Reversible Grade 1-4 thrombocytopenia has been observed in ongoing studies with trastuzumab emtansine.	AE is reported every 3 weeks for the first 12 weeks, then every 9 weeks for the subsequent 39 weeks, then follow-up up to 5 years after completion of study treatment or until death, whichever occurs first. Median follow-up 3.1 years.
Secondary	Number of SNPs With Top Associations of Trastuzumab Emtansine-induced Grade 2-4 Thrombocytopenia in the T-DM1 Arm	DNA will be genotyped for SNPs and CNV markers using the Infinium Human Omni1 array (1.2 million SNP platform) from Illumina. A gene-based association analyses for thrombocytopenia or bleeding is applied with significancy (p-value). This analysis was only conducted in the T-DM1 arm.	DNA sample collected at pre-treatment. AE is reported every 3 weeks for the first 12 weeks, then every 9 weeks for the subsequent 39 weeks.
Secondary	Percentage of Patients With Amenorrhea	All grade 3 - 4 adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv4 as reported on case report forms were counted. Incidence is the number of patients experiencing at least one treatment-related grade >=3 AE of any type during the time of observation.; For those who were premenopausal pre-chemotherapy, at each follow-up visit (every six months) in order to assess for duration of amenorrhea and also premature ovarian failure.	Surveys are took at month 6 and 12 during treatment, and month 18, 24, 30 and 36 during follow up.
Secondary	Gene Mutation Assessed Using High-throughput Mutation Profiling System (Oncomap)	Archival tumor tissue from all patients will be assessed using a high-throughput mutation profiling system (Oncomap) to query a large panel of cancer gene mutations.	After treatment
Secondary	Median Overall Survival (OS)	OS is evaluated in patients with Stage I HER2-positive breast cancer treated with trastuzumab emtansine	Reported every 3 weeks for the first 12 weeks, then every 9 weeks for the subsequent 39 weeks, then follow-up up to 5 years after completion of study treatment or until death, whichever occurs first.