Trial of Neoadjuvant THP vs TCHP for HER2-Amplified/Positive Breast Cancer
A Randomized Trial of Neoadjuvant THP vs TCHP for HER2-amplified/Positive Breast Cancer (NeoTHERa)
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
Not stated in the study description — ask the study team about visits and procedures.
- 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 drug treatments given before surgery for early HER2-positive breast cancer, which has extra HER2 protein or gene copies. Both use docetaxel, Herceptin, and Perjeta; one also adds carboplatin. The study checks how often no cancer is found in tissue removed during surgery.
This is a randomized phase II study to evaluate the pathological complete response (pCR) rate with two neoadjuvant regimens (Docetaxel+Carboplatin+Herceptin/Perjeta and Docetaxel+Herceptin/Perjeta) in HER2 amplified/positive early breast cancer.
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. You or your legal representative must understand the study and sign a consent form.
- Have HER2-positive breast cancer confirmed by a tissue test, with a tumor size and lymph node status allowed by the study. Any estrogen or progesterone hormone test result is allowed.
- Have had no surgery on the affected breast or other treatment for the current breast cancer.
- Be fully active or able to do light work, with this checked within 28 days before treatment. Have no moderate or worse nerve damage.
- Have breast and underarm scans within 7 weeks before treatment. Abnormal underarm or inner chest lymph nodes need a tissue or needle test unless unsafe.
- Join the PRO-HER2 patient registry. Stored tissue from the breast tumor must be obtained or requested.
- Not be pregnant or breastfeeding. If you can become pregnant, agree to follow the study center's birth control rules.
- Have blood counts, liver tests, and a heart scan that meet study limits within the required time.
Who can't join
- Use or plan to use other experimental drugs during the study.
- Have breast cancer that has spread to distant parts of the body.
- Have inflammatory breast cancer.
- Have another past or current cancer that could affect study safety or results. Certain fully treated skin cancers and noninvasive breast or cervical cancers are allowed.
- Have had an allergic reaction to carboplatin, docetaxel, trastuzumab (Herceptin), or pertuzumab (Perjeta).
- Have a condition, treatment, or test result that the study doctor believes could affect results, prevent full participation, or make joining unsafe.
- Be pregnant, breastfeeding, or planning to become pregnant from screening through 120 days after the last treatment dose.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent * 18 years of age or older * Histologically confirmed cT2-T3 N0-N2, cT1 N1-N2, or cTX N1-N2 HER2 positive breast cancer (The invasive tumor must be HER2-positive based on the current ASCO-CAP guidelines; Patients are eligible regardless of estrogen receptor (ER) or progesterone receptor (PR) expression status. However, percentage of both ER and PR positivity must be documented in the pathology report.) * No previous ipsilateral breast surgery for the current breast cancer * No previous chemotherapy, anti-HER2 therapy, immunotherapy, endocrine therapy, or radiotherapy for the current breast cancer * ECOG Performance Status 0-1 documented within 28 days prior to the start of study treatment (Appendix A) * Breast and axillary imaging (including mammogram, ultrasound and/or MRI, per standard of care) within 49 days (7 weeks) prior to treatment initiation * Subjects with clinically and/or radiographically abnormal axillary or internal mammary lymph nodes should have pathologic confirmation of disease status with image-guided biopsy or fine needle aspiration unless deemed medically unsafe * Co-enrollment in the PRO-HER2 (HSC #160944) observational registry protocol * Archival breast tumor tissue has been obtained or has been requested for use, which should include either a formalin-fixed paraffin-embedded (FFPE) block, or sixteen slides (fourteen 5-micron uncharged unstained slides plus either two H\&E slides or two 5-micron charged unstained slides) - from primary breast tumor only. * Subjects with bilateral synchronous HER2 positive breast cancer are eligible if they meet other eligibility criteria * Neuropathy: No baseline grade 2 or above neuropathy * Not pregnant, not breastfeeding, and at least one of the following applies: Not a woman of reproductive potential as defined by institutional standards; A woman of reproductive potential who agrees to follow contraceptive guidelines per institutional standards * Adequate organ function, defined as follows: Hematologic (assessed ≤ 21 days of treatment initiation): Absolute neutrophil count ≥ 1,500/μL (with the exception of patients with documented Fy(a-/b-) (Duffy null) immunophenotype, in which case absolute neutrophil count ≥1,200/uL is allowed), Platelets ≥ 100,000/μL, Leukocytes ≥ 3,000/μL, Hemoglobin ≥ 9.0 g/dL or ≥ 5.6 mmol/L (must be met without erythropoietin dependency and without erythrocyte transfusion within the last two weeks); Hepatic (assessed ≤ 21 days of treatment initiation): Total bilirubin ≤ 1.5x ULN, AST(SGOT) and ALT(SPGT) ≤ 2x ULN, Serum albumin ≥ 3.0 g/dL; Cardiac (assessed ≤ 49 days of treatment initiation): Normal baseline echocardiogram or MUGA scan including LVEF ≥ 50%, per standard of care Exclusion Criteria: * Current or anticipated use of other investigational agents while participating in this study * Clinically or radiographically detected metastatic disease * Inflammatory breast cancer * Prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the treatment regimen. Note: Patients with squamous cell or basal cell carcinoma of the skin, ductal carcinoma in situ (DCIS) of the breast, or carcinoma in situ (CIS) of the uterine cervix who have undergone definitive therapy are not excluded from participation * History of allergic reactions attributed to carboplatin, docetaxel, trastuzumab, or pertuzumab * History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of this study, interfere with the subject's participation for the full duration of the study, or it is not in the best interest of the subject to participate, in the opinion of the treating investigator * Pregnancy, breastfeeding, or expecting to conceive within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment. There is a potential for congenital abnormalities and for this regimen to harm breastfeeding infants.
Study sites (8)
KS
- The University of Kansas Cancer Center (KUCC) · Fairway, KS 66205Clinical Trials Nurse Navigator · Study contact · 913-945-7552 · ctnursenav@kumc.eduMore trials in Fairway
- The University of Kansas Cancer Center - Westwood · Kansas City, KS 66205Clinical Trial Nurse Navigator · Study contact · 913-945-7552 · ctnursenav@kumc.eduMore trials in Kansas City
- KUCC - Indian Creek · Overland Park, KS 66211Nurse Navigator · Study contact · 913-945-7552More trials in Overland Park
- KUCC - Overland Park · Overland Park, KS 66215Nurse Navigator · Study contact · 913-945-7552More trials in Overland Park
- KUCC - Briarcliff · Westwood, KS 66205Nurse Navigator · Study contact · 913-945-7552More trials in Westwood
- KUCC - Olathe · Westwood, KS 66205Nurse Navigator · Study contact · 913-945-7552More trials in Westwood
MO
- The University of Kansas Cancer Center - North · Kansas City, MO 64154Clinical Trial Nurse Navigator · Study contact · 913-945-7552 · ctnursenav@kumc.eduMore trials in Kansas City
- KUCC - Lee's Summit · Lee's Summit, MO 64064Nurse Navigator · Study contact · 913-945-7552More trials in Lee's Summit