T-DM1 vs TH for Breast Cancer
Recruiting in Palo Alto (17 mi)
+54 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Dana-Farber Cancer Institute
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?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
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot receive hormonal therapy during the first 12 weeks of the study treatment.
What data supports the effectiveness of the drug T-DM1 for breast cancer?
T-DM1 has shown a survival advantage in patients with advanced HER2-positive breast cancer, as demonstrated in the EMILIA trial and other studies. It is effective in targeting cancer cells while minimizing side effects, and it has improved outcomes for patients with advanced breast cancer.
12345Is T-DM1 safe for humans?
T-DM1 (Kadcyla) has been studied in various clinical trials for HER2-positive breast cancer, showing a known safety profile. Common side effects include skin reactions, and more serious side effects can occur, but it is generally considered safe for use in humans with careful monitoring.
16789How is the drug T-DM1 different from other breast cancer treatments?
T-DM1 is unique because it is an antibody-drug conjugate specifically designed for HER2-positive breast cancer, combining the targeted action of trastuzumab with the chemotherapy agent emtansine, allowing it to deliver chemotherapy directly to cancer cells. This targeted approach can be more effective and potentially have fewer side effects compared to traditional chemotherapy.
13101112Eligibility Criteria
This trial is for adults with HER2-positive, Stage I breast cancer that's been surgically removed and has no lymph node involvement or only micrometastases. Participants must have good liver and bone marrow function, clear surgical margins, an ECOG status of 0 or 1, and a heart ejection fraction ≥50%. It excludes those with prior chemotherapy within 5 years, certain other cancers, active severe illnesses, pregnant/nursing women, or those not using contraception.Inclusion Criteria
My tumor was completely removed with surgery and the edges were cancer-free.
My cancer has spread to nearby lymph nodes, as found by a sentinel node test.
My cancer is confirmed HER2 positive by a central lab.
My cancer's hormone receptor status was tested.
I am fully active or restricted in physically strenuous activity but can do light work.
I am premenopausal and have a negative pregnancy test.
My breast cancer is HER2-positive, early stage, and has not spread to lymph nodes or only has tiny cancer cells in them.
Exclusion Criteria
I have had breast cancer before.
I have an active liver condition.
I have had chemotherapy or paclitaxel therapy in the last 5 years.
My cancer was advanced but localized when diagnosed.
Participant Groups
The ATEMPT 2.0 study compares two post-surgery treatments for early-stage HER2-positive breast cancer: Trastuzumab-emtansine (T-DM1) versus a combination of Subcutaneous Trastuzumab (Herceptin Hylecta) and Paclitaxel. The goal is to see which therapy better prevents cancer recurrence.
2Treatment groups
Experimental Treatment
Group I: Arm B: Paclitaxel with Trastuzumab SC, followed by Trastuzumab SC aloneExperimental Treatment2 Interventions
Randomized participants will receive weekly intravenous Paclitaxel for 12 weeks (4 cycles) and Trastuzumab SC (subcutaneous) every 3 weeks for 17 cycles. The first 4 doses Trastuzumab SC are given with Paclitaxel.
Group II: Arm A. T-DM1 followed by Trastuzumab SCExperimental Treatment2 Interventions
Randomized participants will receive intravenous T-DM1 every 3 weeks for 6 cycles (18 weeks) and then Trastuzumab SC (subcutaneous) every 3 weeks for 11 cycles
Paclitaxel is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Taxol for:
- Ovarian cancer
- Breast cancer
- Non-small cell lung cancer
- Kaposi's sarcoma
🇪🇺 Approved in European Union as Taxol for:
- Ovarian cancer
- Breast cancer
- Non-small cell lung cancer
- Kaposi's sarcoma
🇨🇦 Approved in Canada as Paclitaxel for:
- Ovarian cancer
- Breast cancer
- Non-small cell lung cancer
- Kaposi's sarcoma
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Stefanie Spielman Comprehensive Breast CenterColumbus, OH
New England Cancer Specialists - PortsmouthPortsmouth, NH
SCRI Oncology PartnersNashville, TN
Tennessee Oncology - NashvilleNashville, TN
More Trial Locations
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Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
Genentech, Inc.Industry Sponsor
References
Ado-trastuzumab emtansine (T-DM1) in human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer: latest evidence and clinical potential. [2022]In February 2013, ado-trastuzumab emtansine (T-DM1, Kadcyla®) received regulatory approval in the United States for treatment-refractory human epidermal growth factor receptor 2 (HER2) positive metastatic or locally advanced breast cancer based on results from EMILIA, a large phase III trial that compared standard of care lapatinib plus capecitabine to T-DM1. Several other studies have been reported in the metastatic setting and multiple trials are ongoing or planned in the neoadjuvant, adjuvant and advanced disease settings. Here we provide an updated and comprehensive review of clinical trials evaluating T-DM1, discuss management of toxicity associated with this drug, propose potential mechanisms of resistance and offer practical considerations for the treating oncologist.
Efficacy and safety of trastuzumab emtansine in older patients with HER2-positive advanced breast cancer: a real-world study. [2022]Ado-trastuzumab emtansine (T-DM1) is an antibody-drug conjugate and its survival advantage has been shown in advanced human epidermal growth factor receptor 2 (HER2)-positive breast cancer. However, clinical trials underrepresent patients ⩾65 years of age, leading to a lack of information in this population. We analyzed the real-world outcomes of older women who were treated with T-DM1 therapy.
Real-world effectiveness of post-trastuzumab emtansine treatment in patients with HER2-positive, unresectable and/or metastatic breast cancer: a retrospective observational study (KBCSG-TR 1917). [2023]Trastuzumab emtansine (T-DM1) is a second-line standard therapy for patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer. Evidence regarding post-T-DM1 treatments is currently lacking. We evaluated the effectiveness of post-T-DM1 drug therapy in patients with HER2-positive, unresectable and/or metastatic breast cancer.
Safety and efficacy of T-DM1 in patients with advanced HER2-positive breast cancer The Royal Marsden experience. [2021]Ado-trastuzumab emtansine (T-DM1) is standard of care for patients with advanced HER2+ breast cancer who relapse within 6 months of adjuvant trastuzumab or progress on first-line anti-HER2 therapy. We evaluated its safety and efficacy in our real-world population.
[Clinical research progress of T-DM1 in breast cancer]. [2021]Ado-trastuzumab emtansine (T-DM1) is an antibody-drug conjugate (ADC) composed of trastuzumab, a linker, and a microtubule inhibitor. T-DM1 combines the highly effective targeting of antibody with the high anti-tumor activity of cytotoxic drugs, while reduces the off-target toxic side effects of cytotoxic drugs. T-DM1 has been applied in neoadjuvant therapy of HER2-positive breast cancer and rescue treatment of advanced breast cancer, greatly improves the prognosis of breast cancer patients. More and more clinical trials of T-DM1 for HER2 breast cancer and other solid tumors are ongoing, and more positive results are expected.
Safety Profile and Costs of Related Adverse Events of Trastuzumab Emtansine for the Treatment of HER2-Positive Locally Advanced or Metastatic Breast Cancer Compared to Capecitabine Plus Lapatinib from the Perspective of the Canadian Health-Care System. [2019]Trastuzumab emtansine (T-DM1, KADCYLA(®)) is an antibody-drug conjugate comprised of the cytotoxic agent DM1 and trastuzumab (HERCEPTIN(®)). The safety profile of T-DM1 in human epidermal growth factor receptor 2 (HER2)-positive locally advanced or metastatic breast cancer previously treated with trastuzumab and a taxane was investigated in the phase III EMILIA trial. The trial demonstrated clinically and statistically meaningful differences in the safety profile between T-DM1 and capecitabine plus lapatinib (CAP + LAP). The objective of this study was to estimate the costs of managing treatment-related grade ≥ 3 adverse events (AEs) that occurred in ≥ 2% of patients and grade 2 AEs that occurred in ≥ 5% of patients taking T-DM1 compared with patients taking CAP + LAP based on the EMILIA trial, from the perspective of Canadian public payers.
Trastuzumab Emtansine: A Review of Its Adjuvant Use in Residual Invasive HER2-Positive Early Breast Cancer. [2022]Trastuzumab emtansine (Kadcyla®), an antibody-drug conjugate of trastuzumab (Herceptin®) connected by a thioether linker to the microtubule inhibitor DM1 (a cytotoxic derivative of maytansine), provides direct intracellular delivery of the potent cytotoxin DM1 to HER2-overexpressing cells, while retaining trastuzumab activity. Its approval in metastatic/advanced breast cancer (BC) has been extended to include single-agent adjuvant treatment of HER2-positive early BC in patients with residual invasive disease in the breast and/or lymph nodes after neoadjuvant taxane-based and HER2-targeted treatment. In the pivotal KATHERINE trial in this population, significantly more trastuzumab emtansine than trastuzumab recipients were estimated to be free of invasive disease recurrence at 3 years, with a 50% reduction in the risk of invasive disease recurrence or death. The tolerability of trastuzumab emtansine in early BC was consistent with its known safety profile; as expected, adverse events were more common with trastuzumab emtansine than with trastuzumab. Recently updated international and national treatment guidelines recommend trastuzumab emtansine as a preferred option in this high-risk BC population.
Trastuzumab Emtansine Plus Pertuzumab Versus Taxane Plus Trastuzumab Plus Pertuzumab After Anthracycline for High-Risk Human Epidermal Growth Factor Receptor 2-Positive Early Breast Cancer: The Phase III KAITLIN Study. [2023]We aimed to improve efficacy and reduce toxicity of high-risk human epidermal growth factor receptor 2 (HER2)-positive early breast cancer (EBC) treatment by replacing taxanes and trastuzumab with trastuzumab emtansine (T-DM1).
Acute skin radiation toxicity seen with concurrent T-DM1: A single institutional report of 35 patients. [2023]Trastuzumab emtansine (T-DM1) is a novel therapeutic for HER2+ breast cancer patients with residual disease after neoadjuvant chemotherapy. Concurrent radiotherapy (RT) is offered to a subset of patients based on results from the KATHERINE trial which showed a favorable safety profile. With emerging therapies that necessitate concurrent RT, we must closely follow rates of skin toxicity. Our first 35 patients who underwent concurrent T-DM1 treatment with breast/chest wall (CW) ± nodal irradiation are reported. Most patients (22/35) had grade 2+ toxicity and 3 patients had grade 3 toxicities. We add our experience with radiation dermatitis and concurrent T-DM1 to contribute to existing reports.
Impact of obesity on safety outcomes and treatment modifications with ado-trastuzumab emtansine in breast cancer patients. [2021]Ado-trastuzumab emtansine (T-DM1) is an antibody-drug conjugate indicated for the treatment of HER2-positive breast cancer. The 2012 American Society of Clinical Oncology guidelines on chemotherapy dosing in obesity recommend using full weight-based cytotoxic chemotherapy doses to treat obese patients with cancer. These guidelines were published prior to the advent of anticancer antibody-drug conjugates. There is a need to investigate the safety of T-DM1 in obese patients.
Impacts of clinicopathological factors on efficacy of trastuzumab deruxtecan in patients with HER2-positive metastatic breast cancer. [2022]The previous second-line treatment for HER2-positive metastatic breast cancer were ado-trastuzumab emtansine (T-DM1); however, its activity is decreased in tumors with heterogenous, reduced, or loss of HER2 expression. Trastuzumab deruxtecan (T-DXd) has recently been developed as a novel antibody-drug conjugate to overcome resistance to T-DM1. However, clinical evidence on its ability to overcome this resistance is limited.
Cost-effectiveness Analysis of Ado-trastuzumab Emtansine (T-DM1) for the Adjuvant Treatment of Patients With Residual Invasive HER2+ Early Breast Cancer in the United States. [2023]Ado-trastuzumab emtansine (T-DM1) was recently approved for patients with human epidermal growth factor receptor 2 positive (HER2+) early breast cancer (eBC) with residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment. Cost-effectiveness analysis was conducted to compare T-DM1 versus trastuzumab in the United States.