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Breast CancerPhase 2NeoTHERaNCT07220135

Trial of Neoadjuvant THP vs TCHP for HER2-Amplified/Positive Breast Cancer

A Phase 2 study testing Carboplatin, Docetaxel and Trastuzumab (or biosimilar) in people with Breast Cancer, run by University of Kansas Medical Center at 8 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Carboplatin, Docetaxel and Trastuzumab (or biosimilar)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
8 sitesUnited States
Study dates
14 Nov 2025to 14 May 2031
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 14Show fewer
  • 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

Who cannot join

  • 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.

Trial locations and contacts

8 sites in 1 country. Contact the study team or a site near you to ask about taking part.

KUCC Navigation contact

913-588-3671

kucc_navigation@kumc.edu

8 sites in 1 country

United States8 sites, 8 recruiting

  • The University of Kansas Cancer Center (KUCC)

    Fairway, Kansas, 66205

    Clinical Trials Nurse Navigator, 913-945-7552, ctnursenav@kumc.edu

    Recruiting

  • The University of Kansas Cancer Center - Westwood

    Kansas City, Kansas, 66205

    Clinical Trial Nurse Navigator, 913-945-7552, ctnursenav@kumc.edu

    Recruiting

  • The University of Kansas Cancer Center - North

    Kansas City, Missouri, 64154

    Clinical Trial Nurse Navigator, 913-945-7552, ctnursenav@kumc.edu

    Recruiting

  • KUCC - Lee's Summit

    Lee's Summit, Missouri, 64064

    Nurse Navigator, 913-945-7552

    Recruiting

  • KUCC - Indian Creek

    Overland Park, Kansas, 66211

    Nurse Navigator, 913-945-7552

    Recruiting

  • KUCC - Overland Park

    Overland Park, Kansas, 66215

    Nurse Navigator, 913-945-7552

    Recruiting

  • KUCC - Briarcliff

    Westwood, Kansas, 66205

    Nurse Navigator, 913-945-7552

    Recruiting

  • KUCC - Olathe

    Westwood, Kansas, 66205

    Nurse Navigator, 913-945-7552

    Recruiting

Other trials in United States

About this study

Official title: A Randomized Trial of Neoadjuvant THP vs TCHP for HER2-amplified/Positive Breast Cancer (NeoTHERa)

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.

Conditions
Breast Cancer
Being tested
Carboplatin, Docetaxel, Trastuzumab (or biosimilar), Pertuzumab (or biosimilar)
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CarboplatinDrug

    Also called Paraplatin

    All of the treatment being received by the study participants during the course of the study is standard of care.

  • DocetaxelDrug

    Also called Taxotere

    All of the treatment being received by the study participants during the course of the study is standard of care.

  • Trastuzumab (or biosimilar)Drug

    Also called Herceptin

    All of the treatment being received by the study participants during the course of the study is standard of care.

  • Pertuzumab (or biosimilar)Drug

    Also called Perjeta

    All of the treatment being received by the study participants during the course of the study is standard of care.

Study groups in NCT07220135
Study groupRoleWhat they receive
Arm AOtherCarboplatin and docetaxel plus trastuzumab and pertuzumab every 21 days for 6 cycles. Doses and route of administration per institutional standards.
Receives: Drug: Carboplatin; Drug: Docetaxel; Drug: Trastuzumab (or biosimilar); Drug: Pertuzumab (or biosimilar)
Arm BOtherDocetaxel plus trastuzumab and pertuzumab every 21 days for 6 cycles. Doses and route of administration per institutional standards.
Receives: Drug: Docetaxel; Drug: Trastuzumab (or biosimilar); Drug: Pertuzumab (or biosimilar)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathologic complete response (pCR) rate in the breast and axilla in the two treatment arms

    To evaluate the pathological complete response (pCR) rate with two neoadjuvant regimens (Docetaxel+Carboplatin+Herceptin+Perjeta (TCHP) and Docetaxel+Herceptin+Perjeta (THP)) in HER2+ breast cancer.

    Measured: At time of breast surgery

Secondary outcomes (6)

  1. Residual cancer burden (RCB)

    Determine residual cancer burden (RCB) 0+1 rate

    Measured: At time of breast surgery

  2. Assess the toxicity and tolerability of each regimen

    Toxicity will be assessed according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 5.0. Only grade 3 and higher CTCAE toxicities will be collected. Alopecia of any grade will not be collected.

    Measured: Start of study treatment (6 cycles every 21 days) until 30 days after last dose of study treatment.

  3. HER2DX pathological complete response (pCR) score status

    Assess pathological complete response (pCR) and residual cancer burden (RCB) by HER2DX pCR score status. The HER2DX test reports three pCR Likelihood Groups for response (High, Medium and Low).

    Measured: Results of HER2DX testing are expected to be available within 3-6 weeks of submission of FFPE samples

  4. Recurrence-Free Survival (RFS)

    RFS is defined as the time from diagnosis to first recurrence (invasive ipsilateral breast, invasive local/regional, or distant), or to death as a result of any cause.

    Measured: From 3- and 5-years from diagnosis

  5. Event-Free Survival (EFS)

    EFS is defined as the time from diagnosis to first recurrence (invasive ipsilateral breast, invasive local/regional, or distant) or to breast cancer-related death.

    Measured: From 3- and 5-years from diagnosis

  6. Overall Survival (OS)

    OS is defined as the time from diagnosis to death from any cause

    Measured: From 3- and 5-years from diagnosis

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2025
  2. Study start14 Nov 2025
  3. Primary completion14 Nov 2027 (estimated)
  4. Study completion14 May 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07220135
Sponsor's protocol ID
IIT-2025-NeoTHERa
Acronym
NeoTHERa
Status last verified
May 2026
First submitted
13 Oct 2025
Last updated
6 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Harris, J., M. Morrow, and L. Norton, Malignant tumors of the breast, in Cancer: principles and practice of oncology, V.J. DeVita, S. Hellman, and S. Rosenberg, Editors. 1997, Lippincott-Raven: Philadelphia. p. 1557-1602.

  • Untch M, Rezai M, Loibl S, Fasching PA, Huober J, Tesch H, Bauerfeind I, Hilfrich J, Eidtmann H, Gerber B, Hanusch C, Kuhn T, du Bois A, Blohmer JU, Thomssen C, Dan Costa S, Jackisch C, Kaufmann M, Mehta K, von Minckwitz G. Neoadjuvant treatment with trastuzumab in HER2-positive breast cancer: results from the GeparQuattro study. J Clin Oncol. 2010 Apr 20;28(12):2024-31. doi: 10.1200/JCO.2009.23.8451. Epub 2010 Mar 22.

    PubMed 20308670

  • Broglio KR, Quintana M, Foster M, Olinger M, McGlothlin A, Berry SM, Boileau JF, Brezden-Masley C, Chia S, Dent S, Gelmon K, Paterson A, Rayson D, Berry DA. Association of Pathologic Complete Response to Neoadjuvant Therapy in HER2-Positive Breast Cancer With Long-Term Outcomes: A Meta-Analysis. JAMA Oncol. 2016 Jun 1;2(6):751-60. doi: 10.1001/jamaoncol.2015.6113.

    PubMed 26914222

  • Bear HD. Indications for neoadjuvant chemotherapy for breast cancer. Semin Oncol. 1998 Apr;25(2 Suppl 3):3-12. No abstract available.

    PubMed 9566201

  • Fisher B, Bryant J, Wolmark N, Mamounas E, Brown A, Fisher ER, Wickerham DL, Begovic M, DeCillis A, Robidoux A, Margolese RG, Cruz AB Jr, Hoehn JL, Lees AW, Dimitrov NV, Bear HD. Effect of preoperative chemotherapy on the outcome of women with operable breast cancer. J Clin Oncol. 1998 Aug;16(8):2672-85. doi: 10.1200/JCO.1998.16.8.2672.

    PubMed 9704717

  • Kuerer HM, Newman LA, Smith TL, Ames FC, Hunt KK, Dhingra K, Theriault RL, Singh G, Binkley SM, Sneige N, Buchholz TA, Ross MI, McNeese MD, Buzdar AU, Hortobagyi GN, Singletary SE. Clinical course of breast cancer patients with complete pathologic primary tumor and axillary lymph node response to doxorubicin-based neoadjuvant chemotherapy. J Clin Oncol. 1999 Feb;17(2):460-9. doi: 10.1200/JCO.1999.17.2.460.

    PubMed 10080586

  • Green M, Hortobagyi GN. Neoadjuvant chemotherapy for operable breast cancer. Oncology (Williston Park). 2002 Jul;16(7):871-84, 889; discussion 889-90, 892-4, 897-8.

    PubMed 12164555

  • van der Hage JA, van de Velde CJ, Julien JP, Tubiana-Hulin M, Vandervelden C, Duchateau L. Preoperative chemotherapy in primary operable breast cancer: results from the European Organization for Research and Treatment of Cancer trial 10902. J Clin Oncol. 2001 Nov 15;19(22):4224-37. doi: 10.1200/JCO.2001.19.22.4224.

    PubMed 11709566

  • Valero V, Buzdar AU, McNeese M, Singletary E, Hortobagyi GN. Primary chemotherapy in the treatment of breast cancer: the University of Texas M. D. Anderson Cancer Center experience. Clin Breast Cancer. 2002 Oct;3 Suppl 2:S63-8. doi: 10.3816/cbc.2002.s.014.

    PubMed 12435294

  • Wang J, Buchholz TA, Middleton LP, Allred DC, Tucker SL, Kuerer HM, Esteva FJ, Hortobagyi GN, Sahin AA. Assessment of histologic features and expression of biomarkers in predicting pathologic response to anthracycline-based neoadjuvant chemotherapy in patients with breast carcinoma. Cancer. 2002 Jun 15;94(12):3107-14. doi: 10.1002/cncr.10585.

    PubMed 12115341

  • Cortazar, P., et al., Meta-analysis results from the collaborative trials in neoadjuvant breast cancer (CTNeoBC) [abstract]. Cancer Res, 2012. 72(24 Suppl): p. Abstract nr P1-14-20.

  • Slamon D, Eiermann W, Robert N, Pienkowski T, Martin M, Press M, Mackey J, Glaspy J, Chan A, Pawlicki M, Pinter T, Valero V, Liu MC, Sauter G, von Minckwitz G, Visco F, Bee V, Buyse M, Bendahmane B, Tabah-Fisch I, Lindsay MA, Riva A, Crown J; Breast Cancer International Research Group. Adjuvant trastuzumab in HER2-positive breast cancer. N Engl J Med. 2011 Oct 6;365(14):1273-83. doi: 10.1056/NEJMoa0910383.

    PubMed 21991949

  • Schneeweiss A, Chia S, Hickish T, Harvey V, Eniu A, Hegg R, Tausch C, Seo JH, Tsai YF, Ratnayake J, McNally V, Ross G, Cortes J. Pertuzumab plus trastuzumab in combination with standard neoadjuvant anthracycline-containing and anthracycline-free chemotherapy regimens in patients with HER2-positive early breast cancer: a randomized phase II cardiac safety study (TRYPHAENA). Ann Oncol. 2013 Sep;24(9):2278-84. doi: 10.1093/annonc/mdt182. Epub 2013 May 22.

    PubMed 23704196

  • von Minckwitz G, Schneeweiss A, Loibl S, Salat C, Denkert C, Rezai M, Blohmer JU, Jackisch C, Paepke S, Gerber B, Zahm DM, Kummel S, Eidtmann H, Klare P, Huober J, Costa S, Tesch H, Hanusch C, Hilfrich J, Khandan F, Fasching PA, Sinn BV, Engels K, Mehta K, Nekljudova V, Untch M. Neoadjuvant carboplatin in patients with triple-negative and HER2-positive early breast cancer (GeparSixto; GBG 66): a randomised phase 2 trial. Lancet Oncol. 2014 Jun;15(7):747-56. doi: 10.1016/S1470-2045(14)70160-3. Epub 2014 Apr 30.

    PubMed 24794243

  • Villacampa G, Matikas A, Oliveira M, Prat A, Pascual T, Papakonstantinou A. Landscape of neoadjuvant therapy in HER2-positive breast cancer: a systematic review and network meta-analysis. Eur J Cancer. 2023 Sep;190:112885. doi: 10.1016/j.ejca.2023.03.042. Epub 2023 Apr 8.

    PubMed 37142539

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Carboplatin, Docetaxel and Trastuzumab (or biosimilar) in people with Breast Cancer, run by University of Kansas Medical Center at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact KUCC Navigation (913-588-3671, kucc_navigation@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathologic complete response (pCR) rate in the breast and axilla in the two treatment arms (time frame: At time of breast surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07220135, which also lists 29 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.

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