Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

512

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline

Completed

Started May 2013

Longer than P75 for phase_2 breast-cancer

Geographic Reach

1 country

85 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

9.1 years study duration

First Submitted

Initial submission to the registry

April 24, 2013

Completed

7 days until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed

14 days until next milestone

First Posted

Study publicly available on registry

May 15, 2013

Completed

6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 26, 2019

Completed

2.4 years until next milestone

Results Posted

Study results publicly available

January 19, 2022

Completed

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2022

Completed

Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

6.3 years

First QC Date

April 24, 2013

Results QC Date

July 21, 2021

Last Update Submit

February 18, 2026

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

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.
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 Outcomes (21)

Incidence Rate of Grade 3-4 Treatment-Related Toxicity
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.
Quality of Life (QOL) FACT B Total Score at Baseline
at baseline
Quality of Life (QOL) FACT B Total Score at Week 3
at week 3
Quality of Life (QOL) FACT B Total Score at Week 12
at week 12
Quality of Life (QOL) FACT B Total Score at 6 Months
at 6 months
+16 more secondary outcomes

Study Arms (2)

Trastuzumab emtansine (T-DM1)

ACTIVE COMPARATOR

T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks

Drug: Trastuzumab emtansine

Paclitaxel + Trastuzumab

ACTIVE COMPARATOR

paclitaxel 80 mg/m2 IV weekly and trastuzumab 4 mg/kg IV load, followed by 2 mg/kg IV weekly for 12 weeks, followed by trastuzumab 6 mg/kg IV every 3 weeks for 13 treatments

Drug: TrastuzumabDrug: Paclitaxel

Interventions

TrastuzumabDRUG

Paclitaxel + Trastuzumab

PaclitaxelDRUG

Paclitaxel + Trastuzumab

Trastuzumab emtansineDRUG

Also known as: T-DM1

Trastuzumab emtansine (T-DM1)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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
+1 more criteria

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Dana-Farber Cancer Institutelead

Study Sites (85)

University of Alabama Birmingham

Birmingham, Alabama, 35249, United States

Location

University of California San Francisco

San Francisco, California, 94115, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Midstate Medical Center

Meriden, Connecticut, 06451, United States

Location

Hartford Healthcare Cancer Institute at The Hospital of Central Connecticut

New Britain, Connecticut, 06050, United States

Location

William W Backus Hospital

Norwich, Connecticut, 06360, United States

Location

Georgetown Hospital

Washington D.C., District of Columbia, 20007, United States

Location

Washington Cancer Institute at Medstar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Sibley Memorial Hospital

Washington D.C., District of Columbia, 20016, United States

Location

Florida Cancer Specialists

Fort Myers, Florida, 33916, United States

Location

Florida Cancer Specialists

St. Petersburg, Florida, 337054, United States

Location