RecruitingPhase 2

ATEMPT 2.0: Adjuvant T-DM1 vs TH

A Randomized Phase II Trial of Adjuvant Trastuzumab Emtansine (T-DM1) Followed by Subcutaneous Trastuzumab Versus Paclitaxel in Combination With Subcutaneous Trastuzumab for Stage I HER2-positive Breast Cancer (ATEMPT 2.0)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 5 years
  • Procedures mentioned: Injections

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Trastuzumab is FDA-approved to be administered as an IV (intravenous) or subcutaneous (muscular injection)."
  • "Participants will receive study treatment for a year in total and will be followed for 5 years after treatment."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares two treatments given after surgery for newly diagnosed, stage I breast cancer that tests positive for HER2, a protein that helps cancer grow. The study drugs are T-DM1 (Kadcyla), trastuzumab SC (Herceptin Hylecta), and paclitaxel.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older and able to do most daily activities.
  • Have stage I HER2-positive breast cancer, with no cancer or only tiny amounts in nearby lymph nodes. A central lab must confirm the HER2 result, and hormone receptor testing is required.
  • Have all breast cancer removed by surgery, with nearby lymph nodes checked. Start study treatment within 90 days of the most recent breast surgery.
  • If you had a lumpectomy, which removes part of the breast, you must be able to receive radiation to that breast.
  • Have blood counts, liver tests, and heart pumping strength that meet study limits.
  • Have a negative pregnancy test if required. Use approved birth control without hormones during treatment and for 7 months after the last dose if you or your partner could become pregnant.
  • Have had no more than 4 weeks of hormone treatment for this cancer. Do not take hormone treatment during the first 12 weeks of study treatment.
  • Be willing and able to sign a consent form. Provide tumor tissue for research if available.

Who can't join

  • Be pregnant or breastfeeding, or be unwilling to use the required birth control.
  • Have cancer that was locally advanced at diagnosis, such as cancer attached to the chest wall or causing major skin changes.
  • Have had invasive breast cancer before, or DCIS in the opposite breast. DCIS is cancer that stays inside the milk ducts.
  • Have received chemotherapy in the past 5 years, or ever received paclitaxel.
  • Have active liver disease, such as hepatitis B or C.
  • Have a history of another cancer, unless you have been cancer-free for at least 5 years and have a low risk of it returning. Certain early cervical cancers and non-melanoma skin cancers are allowed.
  • Have already received whole-breast radiation for this cancer. Prior partial-breast radiation is allowed only under certain timing limits.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (53)

CA

  • UCSF Helen Diller Family Comprehensive Cancer Center · San Francisco, CA 94158Hope Rugo, MD · Study contactHope Rugo, MD · Principal investigatorMore trials in San Francisco

CT

  • Smilow Cancer Hospital Care center at Derby · Derby, CT 06418Clinical Trial Offcie Yale Cancer Center · Study contact · (203) 734-1664Daniel O'Neil, MD · Principal investigatorMore trials in Derby
  • Smilow Cancer Hospital Care center at Fairfield · Fairfield, CT 06824Clinical Trials Office Yale Cancer Center · Study contact · (203) 255-2766Daniel O'NEIL, MD · Principal investigatorMore trials in Fairfield
  • Smilow Cancer Hospital Care center at Glastonbury · Glastonbury, CT 06033Clinical Trial Office Yale Cancer Center · Study contact · (860) 714-9170Daniel O'Neil, MD · Principal investigatorMore trials in Glastonbury
  • Smilow Cancer Hospital Care center at Greenwich · Greenwich, CT 06830Clinical Trials Office Yale Cancer Center · Study contact · (203) 863-3700Daniel O'Neil, MD · Principal investigatorMore trials in Greenwich
  • Smilow Cancer Hospital Care center at Guilford · Guilford, CT 06437Clinical Trial Office Yale Cancer Center · Study contact · (203) 453-9192Daniel O'Neil, MD · Principal investigatorMore trials in Guilford
  • Smilow Cancer Hospital Care center at St. Francis · Hartford, CT 06105Clinical Trial Office Yale Cancer Center · Study contact · (860) 714-4680Daniel O'Neil, MD · Principal investigatorMore trials in Hartford
  • Smilow Cancer Hospital Care center at Long Ridge · Long Ridge, CT 06902Clinical Trial Office Yale Center · Study contact · (203) 863-3700Daniel O'Neil, MD · Principal investigatorMore trials in Long Ridge
  • Yale Cancer Center at Yale University School of Medicine · New Haven, CT 06520-8028Clinical Trial Office Clinical Trials Office - Yale Cancer Center · Study contact · 203-785-5702Daniel O'Niel, MD · Principal investigatorMore trials in New Haven
  • Smilow Cancer Hospital Care center at North Haven · North Haven, CT 06510Clinical Trials Office Yale Cancer Center · Study contact · (203) 407-8002Daniel O'neil, MD · Principal investigatorMore trials in North Haven
  • Stamford Hospital · Stamford, CT 06904K.M. Steve Lo, MD · Study contact · slo@stamhealth.orgK. M. Steve Lo, MD · Principal investigatorMore trials in Stamford
  • Smilow Cancer Hospital Care center at Torrington · Torrington, CT 06790Clinical Trial Office Yale Cancer Center · Study contact · (860) 482-5384Daniel O'Neil, MD · Principal investigatorMore trials in Torrington
  • Smilow Cancer Hospital Care center at Trumbull · Trumbull, CT 06611Clinical Trials Office Cancer Trial · Study contact · (203) 502-8400Daniel O'Neil, MD · Principal investigatorMore trials in Trumbull
  • Smilow Cancer Hospital Care center at Waterbury · Waterbury, CT 06708Clinical Trials Office Yale Cancer Center · Study contact · (203) 755-6311Daniel O'Neil, MD · Principal investigatorMore trials in Waterbury
  • Smilow Cancer Hospital Care center at Waterford · Waterford, CT 06385Clinical Trials Office Yale Cancer Center · Study contact · (860) 444-3744Daniel O'Neil, MD · Principal investigatorMore trials in Waterford

FL

IL

IN

MA

ME

NC

NH

NY

OH

  • Stefanie Spielman Comprehensive Breast Center · Columbus, OH 43212Breast Cancer Clinical Trials · Study contact · 800-293-5066Gilbert Bader, MD · Principal investigatorMore trials in Columbus

PA

RI

  • Smilow Cancer Hospital Care center at Westerly · Westerly, RI 02891Clinical Trials Office Yale Cancer Center · Study contact · (401) 656-4950Daniel O'Neil, MD · Principal investigatorMore trials in Westerly

TN

TX