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Clinical Trials in Israel / NCT04893109
Recruiting Phase 2

ATEMPT 2.0: Adjuvant T-DM1 vs TH

NCT04893109 · tracked via the Priya Life Science Israel tracker
Phase
Phase 2
Started
2021-06-16
Last updated
2026-08-19

Condition(s) studied

Breast CancerHER2-positive Breast Cancer

Investigational drug(s) / intervention(s)

trastuzumab-emtansine →Trastuzumab SC →Paclitaxel →

trastuzumab-emtansine: intravenous infusion

Trastuzumab SC: Muscular injection

Paclitaxel: intravenous infusion

Study summary

This research study is studying how well newly diagnosed breast cancer that has tested positive for a protein called HER2 responds using one of two different combination of HER2-directed therapies as a treatment after surgery.

The name of the study drugs involved are:

* Trastuzumab-emtansine (T-DM1, Kadcyla)
* Trastuzumab SC (Herceptin Hylecta)
* Paclitaxel

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients must have HER2-positive Stage I histologically confirmed invasive carcinoma of the breast. Patients must have node-negative (N0) or micrometastases (N1mic) breast cancer according to the AJCC 8th edition anatomic staging table. * If the patient has had a negative sentinel node biopsy, then no further axillary dissection is required, and the patient is determined to be node-negative. If an axillary dissection without sentinel lymph node biopsy is performed to determine nodal status, at least six axillary lymph nodes must be removed and analyzed, and determined to be negative, for the patient to be considered node-negative. Axillary nodes with single cells or tumor clusters ≤ 0.2 mm by either H\&E or immunohistochemistry (IHC) will be considered node-negative. * Any axillary lymph node with tumor clusters between 0.02 and 0.2 cm is considered a micrometastasis. Patients with a micrometastasis are eligible. An axillary dissection is not required to be performed in patients with a micrometastasis found by sentinel node evaluation. In cases where the specific pathologic size of lymph node involvement is subject to interpretation, the principal investigator will make the final determination as to eligibility. The investigator must document approval in the patient medical record. * Patients who have an area of a T1aN0, ER+ (defined as \>10%), HER2-negative cancer in addition to their primary HER2-positive tumor are eligible. * HER2-positive by ASCO CAP 2018 guidelines, confirmed by central testing. NOTE: HER-2 status must be confirmed to be positive by central review by NeoGenomics prior to patient starting protocol therapy. Patients previously having had HER2 immunohistochemical testing by NeoGenomics do not need to undergo retesting for central confirmation of HER2 status. NOTE: DCIS components will not be counted in the determination of HER2 status * ER/PR determination is required. ER and PR assays should be performed by immunohistochemical methods according to the local institution standard protocol. * Bilateral breast cancers that individually meet eligibility criteria are allowed. * Patients with multifocal or multicentric disease are eligible, as long as each tumor individually meets eligibility criteria. Central confirmation is needed for any site of disease that is tested to be HER2-positive by local testing (unless testing was previously done by NeoGenomics). * Patients with a history of ipsilateral DCIS are eligible if they were treated with wide excision alone, without radiation therapy, or treated with a mastectomy for this current breast cancer. Patients with a history of contralateral DCIS are not eligible. * ≤ 90 days between the planned treatment start date and the patient's most recent breast surgery for this breast cancer * ≥ 18 years of age with any menopausal status. * ECOG Performance Status 0 or 1 * 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 (i.e. no tumor on ink). The local pathologist must document negative margins of resection in the pathology report. If all other margins are clear, a positive posterior (deep) margin is permitted, provided the surgeon documents that the excision was performed down to the pectoral fascia and all tumor has been removed. Likewise, if all other margins are clear, a positive anterior (superficial; abutting skin) margin is permitted provided the surgeon documents that all tumor has been removed. * Patients undergoing breast conservation therapy (i.e. lumpectomy) must not have any contraindications to radiation therapy. Radiation to the conserved breast is required. * Patients may have received up to 4 weeks of tamoxifen therapy, or other hormonal therapy, for adjuvant therapy for this cancer. Patients cannot receive adjuvant hormonal therapy during protocol treatment for the first 12 weeks. * Prior oophorectomy for cancer prevention is allowed. * Patients who have undergone partial breast radiation (duration ≤ 14 days) prior to registration are eligible. Partial breast radiation must be completed prior to 2 weeks before starting protocol therapy. Patients who have undergone whole breast radiation are not eligible. * Patients who have participated in a window study (treatment with an investigational agent prior to surgery for ≤ 2 weeks) are eligible. Patients must have discontinued the investigational agent at least 14 days before participation. * Adequate bone marrow function: * ANC ≥ 1000/mm3, * Hemoglobin ≥ 9 g/dl * Platelets ≥ 100,000/mm3 * Adequate hepatic function: * Total bilirubin ≤ 1.2mg/dL * AST and ALT ≤ 1.5x Institutional ULN * For patients with Gilbert syndrome, the direct bilirubin should be within the institutional normal range. Serum alkaline phosphatase should be ≤ 1.5x Institutional ULN. * Left ventricular ejection fraction (LVEF) ≥ 50% * Premenopausal patients must have a negative serum or urine pregnancy test, including women who have had a tubal ligation and for women less than 12 months after the onset of menopause. * Women of childbearing potential and men with partners of childbearing potential must be willing to use one highly effective form of nonhormonal contraception or two effective forms of nonhormonal contraception by the patient and/or partner. Contraceptive use must be continued for the duration of the study treatment and for 7 months after the last dose of study treatment. Hormonal birth control methods are not permitted. * Patients should have tumor tissue available, and a tissue block of sufficient size to make 15 slides, which must be sent to DFCI for correlative research. If a tissue block is unavailable, sites may send one H\&E-stained slide and 15 unstained sections of paraffin-embedded tissue on uncharged slides. Slide sections should be 4-5 microns in thickness. It is also acceptable to submit 2 cores from a block of invasive tissue using a 1.2 mm diameter coring tool. If tumor is not available, the investigator must document why tissue is not available in the patient medical record, and that efforts have been made to obtain tissue. * Willing and able to sign informed consent * Must be able to read and understand English in order to participate in the quality of life surveys. If patient does not read and understand English, the patient is still eligible, but cannot participate in the quality of life surveys. Exclusion Criteria: * Any of the following due to teratogenic potential of the study drugs: * Pregnant women * Nursing women * Women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragms, IUDs, surgical sterilization, abstinence, etc.). * Men who are unwilling to employ adequate contraception (condoms, surgical sterilization, abstinence, etc.). * Locally advanced tumors at diagnosis, including tumors fixed to the chest wall, peau d'orange, skin ulcerations/nodules, or clinical inflammatory changes (diffuse brawny cutaneous induration with an erysipeloid edge) * Patients with a history of previous invasive breast cancer. * History of prior chemotherapy in the past 5 years. * History of paclitaxel therapy * Patients with active liver disease, for example due to hepatitis B virus, hepatitis C virus, autoimmune hepatic disorder, or sclerosing cholangitis * Individuals with a history of a different malignancy are ineligible except for the following circumstances: * Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. * Individuals with the following cancer are eligible regardless of when they were diagnosed and treated: cervical cancer in situ, and non-melanoma cancer of the skin. * Intercurrent illness including, but not limited to: ongoing or active, unresolved systemic infection, renal failure requiring dialysis, active cardiac disease, prior myocardial infarction (asymptomatic changes on EKG suggestive of old MI is not an exclusion), history of CHF, current use of any therapy specifically for CHF, uncontrolled hypertension, significant psychiatric illness, or other conditions that in the opinion of the investigator limit compliance with study requirements.

Primary outcome measure(s)

Trial sites (53)

FacilityCityRegionStatus
UCSF Helen Diller Family Comprehensive Cancer Center San Francisco California Recruiting
Smilow Cancer Hospital Care center at Derby Derby Connecticut Recruiting
Smilow Cancer Hospital Care center at Fairfield Fairfield Connecticut Recruiting
Smilow Cancer Hospital Care center at Glastonbury Glastonbury Connecticut Recruiting
Smilow Cancer Hospital Care center at Greenwich Greenwich Connecticut Recruiting
Smilow Cancer Hospital Care center at Guilford Guilford Connecticut Recruiting
Smilow Cancer Hospital Care center at St. Francis Hartford Connecticut Recruiting
Smilow Cancer Hospital Care center at Long Ridge Long Ridge Connecticut Recruiting
Yale Cancer Center at Yale University School of Medicine New Haven Connecticut Recruiting
Smilow Cancer Hospital Care center at North Haven North Haven Connecticut Recruiting
Stamford Hospital Stamford Connecticut Recruiting
Smilow Cancer Hospital Care center at Torrington Torrington Connecticut Recruiting
Smilow Cancer Hospital Care center at Trumbull Trumbull Connecticut Recruiting
Smilow Cancer Hospital Care center at Waterbury Waterbury Connecticut Recruiting
Smilow Cancer Hospital Care center at Waterford Waterford Connecticut Recruiting
Miami Cancer Institute/Baptist Hospital of Miami Miami Florida Recruiting
Miami Cancer Institute - Plantation (MCIP) Plantation Florida Recruiting
The University of Chicago Medical Center Chicago Illinois Recruiting
Indiana University Health Joe & Shelly Schwarz Cancer Center Carmel Indiana Active Not Recruiting
IU Health North Hospital Carmel Indiana Active Not Recruiting
Indiana University Melvin and Bren Simon Comprehensive Cancer Center Indianapolis Indiana Active Not Recruiting
Indiana University Sidney and Lois Eskenazi Hospital Indianapolis Indiana Active Not Recruiting
Eastern Maine Medical Center (Northern Light) Brewer Maine Recruiting
New England Cancer Specialists Scarborough Maine Recruiting
Beth Israel Deaconess Medical Center Boston Massachusetts Active Not Recruiting
Dana Farber Cancer Institute Boston Massachusetts Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
Dana-Farber at St. Elizabeth's Medical Center Brighton Massachusetts Recruiting
Lahey Clinic Burlington Massachusetts Recruiting
Mass General North Shore Cancer Center Danvers Massachusetts Recruiting
Dana-Farber Brigham Cancer Center - Foxborough Foxborough Massachusetts Recruiting
Dana-Farber Cancer Instiute - Merrimack Valley Methuen Massachusetts Recruiting
Dana-Farber at Milford Milford Massachusetts Recruiting
Newton Wellesley Hospital Newton Massachusetts Recruiting
Berkshire Medical Center Pittsfield Massachusetts Recruiting
Dana Farber at South Shore Hospital Weymouth Massachusetts Recruiting
NH Oncology-Hematology, PA - Payson Center for Cancer Care Concord New Hampshire Recruiting
Dana-Farber Cancer Insitute at Londonderry Hospital Londonderry New Hampshire Recruiting
Solinsky Center for Cancer Care (NH Oncology-Hematology, PA) Manchester New Hampshire Recruiting
New England Cancer Specialists - Portsmouth Portsmouth New Hampshire Recruiting

+ 13 more sites — see the full list on the official registry below.

More Dana-Farber Cancer Institute trials in Israel

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04893109 on ClinicalTrials.gov ↗ ← All trials in Israel