Stage IIIC Breast Cancer AJCC v7 Clinical Trial
Official title:
ATOP Trial: Adjuvant Ado-Trastuzumab Emtansine (T-DM1) for Older Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer
This phase II trial studies how well trastuzumab emtansine works in treating older patients with human epidermal growth factor receptor 2 (HER2)-positive stage I-III breast cancer. HER2 is a protein found on the surface of cancer cells that helps them to grow and spread. Trastuzumab emtansine may kill cancer cells by binding to HER2-positive on the surface of the tumor cells and blocking their ability grow and spread.
PRIMARY OBJECTIVES:
I. Invasive disease-free survival (IDFS), defined as occurrence of any of the following:
ipsilateral invasive breast cancer recurrence, regional invasive breast cancer recurrence,
distant recurrence, death attributable to any cause, contralateral invasive breast cancer, or
second non-breast invasive cancer. Note: In-situ events are not included.
SECONDARY OBJECTIVES:
I. Overall survival (OS). II. Recurrence-free survival (RFS). III. Adverse events. IV.
Cardiac function/adverse events. V. Site of first recurrence.
TERTIARY OBJECTIVES:
I. The associations of adverse events and outcomes with each of the following will be
examined: geriatric assessment (GA), patient reported outcomes (Patient-Reported Outcomes
Version of the Common Terminology Criteria for Adverse Event [PRO-CTCAE]), quality of life
(QOL), and biomarkers of aging.
II. To determine whether clinician-reported CTCAEs are more accurate when PRO-CTCAE data are
shared with the patient and clinician.
III. Utilize a high-throughput mutation profiling system (Oncomap) to query a large panel of
cancer gene mutations in older patients with HER2-positive breast cancers.
OUTLINE:
Patients receive trastuzumab emtansine intravenously (IV) over 30-90 minutes on day 1.
Treatment repeats every 21 days for 17 courses in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed up at 6-12 months and then yearly
for 4 years.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03106415 -
Pembrolizumab and Binimetinib in Treating Patients With Locally Advanced or Metastatic Triple Negative Breast Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT02689427 -
Enzalutamide and Paclitaxel Before Surgery in Treating Patients With Stage I-III Androgen Receptor-Positive Triple-Negative Breast Cancer
|
Phase 2 | |
| Completed |
NCT00390455 -
Fulvestrant With or Without Lapatinib in Treating Postmenopausal Women With Stage III or Stage IV Breast Cancer That is Hormone Receptor-Positive
|
Phase 3 | |
| Active, not recruiting |
NCT02754752 -
Electroacupuncture Therapy in Reducing Chronic Pain in Patients After Breast Cancer Treatment
|
Phase 2 | |
| Completed |
NCT03094052 -
Incidence and Severity of Diarrhea in Patients With HER2 Positive Breast Cancer Treated With Trastuzumab and Neratinib
|
Phase 2 | |
| Active, not recruiting |
NCT03317405 -
Phase I Trial of Endoxifen Gel Versus Placebo in Women Undergoing Breast Surgery
|
Phase 1 | |
| Recruiting |
NCT02276443 -
Molecular Testing and Imaging in Improving Response in Patients With Stage I-III Triple-Negative Breast Cancer Receiving Chemotherapy MDACC Breast Moonshot Initiative
|
N/A | |
| Completed |
NCT01251874 -
Veliparib and Carboplatin in Treating Patients With HER2-Negative Metastatic Breast Cancer
|
Phase 1 | |
| Active, not recruiting |
NCT03281902 -
Genetic Analysis in Blood and Tumor Samples From Patients With Advanced or Metastatic Estrogen Receptor Positive and HER2 Negative Breast Cancer Receiving Palbociclib and Endocrine Therapy
|
||
| Active, not recruiting |
NCT02311933 -
Tamoxifen Citrate or Z-Endoxifen Hydrochloride in Treating Patients With Locally Advanced or Metastatic, Estrogen Receptor-Positive, HER2-Negative Breast Cancer
|
Phase 2 | |
| Completed |
NCT01142401 -
Fulvestrant With or Without Bortezomib in Patients With Inoperable Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT01351909 -
Cyclophosphamide and Veliparib in Treating Patients With Locally Advanced or Metastatic Breast Cancer
|
Phase 1 | |
| Recruiting |
NCT03391453 -
Proton Beam Radiation Therapy in Treating Patients With Breast Cancer After Surgery
|
Phase 2 | |
| Recruiting |
NCT03428802 -
Pembrolizumab in Treating Participants With Metastatic, Recurrent or Locally Advanced Cancer and Genomic Instability
|
Phase 2 | |
| Active, not recruiting |
NCT03012100 -
Multi-epitope Folate Receptor Alpha Peptide Vaccine, GM-CSF, and Cyclophosphamide in Treating Patients With Triple Negative Breast Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT01327781 -
Z-Endoxifen Hydrochloride in Treating Patients With Metastatic or Locally Recurrent Estrogen Receptor-Positive Breast Cancer
|
Phase 1 | |
| Active, not recruiting |
NCT01552434 -
Bevacizumab and Temsirolimus Alone or in Combination With Valproic Acid or Cetuximab in Treating Patients With Advanced or Metastatic Malignancy or Other Benign Disease
|
Phase 1 | |
| Completed |
NCT03407716 -
Ginseng in Decreasing Cancer-Related Fatigue After Treatment in Cancer Survivors
|
Early Phase 1 | |
| Active, not recruiting |
NCT01463072 -
Nab-Paclitaxel in Treating Older Patients With Locally Advanced or Metastatic Breast Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT02079662 -
The Role of Lifestyle Factors in Breast Cancer-Related Outcomes
|
N/A |