Breast CancerPhase 2Opti-HER2NCT07421141

De-escalation of Neoadjuvant Treatment (Paclitaxel + HP) in Early HER2+ Breast Cancer

A Phase 2 study testing Paclitaxel, trastuzumab and Pertuzumab in people with Breast Cancer and HER2-positive Breast Cancer, run by National Medical Research Radiological Centre of the Ministry of Health of Russia at 1 site in Russia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

This phase II study evaluates the efficacy and safety of a de-escalated neoadjuvant chemotherapy regimen in patients with early-stage HER2-positive breast cancer. The experimental regimen consists of 12 weekly cycles of paclitaxel combined with trastuzumab and pertuzumab (THP), without anthracyclines. Read more about this study

Who is it for?: Ages 18 to 75 years, women only
Conditions the study is for: Breast Cancer, HER2-positive Breast Cancer, Early Breast Cancer
What is being tested?: Paclitaxel, trastuzumab and Pertuzumab
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 186 participants
Where: 1 siteRussia
Study dates: 1 Sep 2023to 30 Dec 2028
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 to 75 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Histologically confirmed invasive breast carcinoma.
HER2-positive status defined as IHC 3+ or FISH amplification (ratio >= 2.0).
Clinical Stage IIA-IIB (cT1-T2 N0-N1, cT3 N0, M0).
Operable disease planned for surgical resection.
ECOG performance status 0-1.
Left Ventricular Ejection Fraction (LVEF) >= 50% by Echocardiography.
Adequate bone marrow, hepatic, and renal function.
Signed informed consent form.

Who cannot join

Metastatic disease (Stage IV).
Prior systemic therapy for breast cancer (chemotherapy, immunotherapy, or anti-HER2 therapy).
Serious cardiac history (congestive heart failure, unstable angina, myocardial infarction within 6 months).
Other synchronous or metachronous malignancies within 5 years (except non-melanoma skin cancer or carcinoma in situ of the cervix).
Pregnancy or breastfeeding.
Known hypersensitivity to study drugs.

Trial locations and contacts

1 site in 1 country.

Russia1 site

P.A. Hertsen Moscow Oncology Research Institute
Moscow, 125284

Other trials in Russia

About this study

Official title: Prospective Non-Randomized Phase II Study of De-escalated Neoadjuvant Chemotherapy With Paclitaxel, Trastuzumab, and Pertuzumab (THP) Compared to Standard Regimen (TCHP) in Patients With Early HER2-Positive Breast Cancer

The study aims to determine if this less toxic regimen can achieve high rates of pathological complete response (pCR) comparable to standard anthracycline-containing regimens. The results are compared with a historical control group of patients who received the standard TCHP regimen (docetaxel, carboplatin, trastuzumab, pertuzumab).

A total of 186 participants are included in the analysis: 93 patients prospectively treated with the de-escalated THP regimen and 93 patients in the retrospective historical control group (TCHP). The primary endpoint is the pCR rate at the time of surgery. Secondary endpoints include toxicity, rate of breast-conserving surgery, and 3-year event-free survival.

Read the detailed description

Background:

Standard neoadjuvant therapy for HER2-positive breast cancer often includes anthracyclines (AC-THP) or platinum-based regimens (TCHP), which are associated with significant toxicity. De-escalation strategies aim to reduce toxicity without compromising efficacy, particularly in patients with early-stage disease.

Study Design:

This is an investigator-initiated, single-center, open-label, non-randomized phase II study.

Prospective Cohort (n=93): Patients with Stage IIA-IIB (cT1-2 N0-1, cT3 N0) HER2+ breast cancer receive Paclitaxel (80 mg/m2 weekly for 12 weeks) + Trastuzumab (loading 8 mg/kg, then 6 mg/kg q3w) + Pertuzumab (loading 840 mg, then 420 mg q3w).
Historical Control Cohort (n=93): Patients with similar baseline characteristics (Stage IIA-IIB) treated with standard TCHP regimen (Docetaxel 75 mg/m2 + Carboplatin AUC6 + Trastuzumab + Pertuzumab q3w for 6 cycles).

Primary Objective:

To evaluate the pathological complete response (pCR, ypT0/is ypN0) rate in the de-escalated arm.

Secondary Objectives:

To compare the safety profile (incidence of Grade 3-4 adverse events) between THP and TCHP regimens.
To assess the rate of breast-conserving surgery.
To evaluate long-term oncological outcomes (3-year Event-Free Survival).

The study hypothesis is that the de-escalated THP regimen provides a favorable toxicity profile while maintaining high efficacy in a selected population of early HER2+ breast cancer patients.

Conditions: Breast Cancer, HER2-positive Breast Cancer, Early Breast Cancer
Being tested: Paclitaxel, trastuzumab, Pertuzumab, Docetaxel, carboplatin
Keywords: Neoadjuvant Therapy, De-escalation, Paclitaxel, Trastuzumab, Pertuzumab, Pathological Complete Response, THP Regimen
Medical subject headings: Breast Neoplasms

What participants receive

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

PaclitaxelDrug
Also called Taxol
80 mg/m2 IV weekly for 12 weeks
trastuzumabDrug
Also called Herceptin
Loading dose 8 mg/kg, then 6 mg/kg IV every 3 weeks
PertuzumabDrug
Also called Perjeta
Loading dose 840 mg, then 420 mg IV every 3 weeks
DocetaxelDrug
Also called Taxotere
75 mg/m2 IV every 3 weeks for 6 cycles
carboplatinDrug
Also called Paraplatin
AUC 6 IV every 3 weeks for 6 cycles
Radical SurgeryProcedure or surgery
Standard radical resection (mastectomy or breast-conserving surgery) with axillary staging (sentinel lymph node biopsy and/or axillary lymph node dissection [Levels I-II], according to current clinical guidelines).
Adjuvant Systemic TherapyDrug
Also called Trastuzumab, T-DM1, Trastuzumab Emtansine
Risk-adapted post-neoadjuvant treatment based on pathological response:
- Patients with pCR (ypT≤1a, ypN0, RCB 0-I) receive Trastuzumab to complete 1 year of anti-HER2 therapy (combined with endocrine therapy for luminal subtypes).
- Patients with residual disease (ypT≥1b and/or ypN+ and/or RCB II-III) receive Trastuzumab emtansine (T-DM1) 3.6 mg/kg every 3 weeks for up to 14 cycles (combined with endocrine therapy for luminal subtypes).
Adjuvant radiotherapy is administered if clinically indicated.

Study groups in NCT07421141
Study group	Role	What they receive
Experimental: De-escalated THP	Experimental	Patients receive de-escalated neoadjuvant chemotherapy consisting of 12 weekly cycles of Paclitaxel combined with Trastuzumab and Pertuzumab (THP regimen), followed by surgery. Receives: Drug: Paclitaxel; Drug: trastuzumab; Drug: Pertuzumab; Procedure: Radical Surgery; Drug: Adjuvant Systemic Therapy
Historical Control: Standard TCHP	Active comparator	Retrospective cohort of patients who received standard neoadjuvant chemotherapy with Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab (TCHP regimen) for 6 cycles. Receives: Drug: trastuzumab; Drug: Pertuzumab; Drug: Docetaxel; Drug: carboplatin; Procedure: Radical Surgery; Drug: Adjuvant Systemic Therapy

What is being measured

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

Pathological Complete Response (pCR) Rate
Defined as the absence of invasive cancer in the breast and axillary lymph nodes (ypT0/is ypN0) at the time of surgery
Measured: At the time of surgery (approximately 12-18 weeks after treatment initiation)

Secondary outcomes (3)

Incidence of Grade 3-4 Adverse Events
Assessment of treatment-related toxicity (neutropenia, diarrhea, etc.) according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0, where Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life-threatening, and Grade 5 is death.
Measured: From first dose until 30 days after last dose
Rate of Breast-Conserving Surgery
Proportion of patients eligible for and undergoing breast-conserving surgery
Measured: At the time of surgery
3-Year Event-Free Survival (EFS)
Time from enrollment to disease progression, local recurrence, distant metastasis, or death from any cause
Measured: 3 years from enrollment

Timeline

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

1 Sep 202330 Dec 2028

First posted19 Feb 2026
Study start1 Sep 2023
Primary completion10 Dec 2025
Study completion30 Dec 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Breast CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Non-randomised
Intervention model: Parallel groups
Model description: Prospective single-arm de-escalation cohort compared with a retrospective historical control cohort.
Masking: None (open label)
Enrolment: 186 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07421141
Sponsor's protocol ID: Opti-HER2-2023
Other IDs: LEC #962/107
Acronym: Opti-HER2
Status last verified: Feb 2026
First submitted: 9 Feb 2026
Last updated: 27 Feb 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Individual participant data will not be shared due to patient confidentiality requirements

Publications

Nitz UA, Gluz O, Christgen M, Grischke EM, Augustin D, Kuemmel S, Braun M, Potenberg J, Kohls A, Krauss K, Stefek A, Schumacher C, Forstbauer H, Reimer T, Fischer H, Liedtke C, Wuerstlein R, Schumacher J, Kates R, Kreipe H, Harbeck N. De-escalation strategies in HER2-positive early breast cancer (EBC): final analysis of the WSG-ADAPT HER2+/HR- phase II trial: efficacy, safety, and predictive markers for 12 weeks of neoadjuvant dual blockade with trastuzumab and pertuzumab +/- weekly paclitaxel. Ann Oncol. 2017 Nov 1;28(11):2768-2772. doi: 10.1093/annonc/mdx494.
PubMed 28945833
Waks AG, Desai NV, Li T, Poorvu PD, Partridge AH, Sinclair N, Spring LM, Faggen M, Constantine M, Metzger O, Alberti J, Deane J, Rosenberg SM, Frank E, Tolaney SM, Krop IE, Tung NM, Tayob N, King TA, Mittendorf EA, Winer EP. A prospective trial of treatment de-escalation following neoadjuvant paclitaxel/trastuzumab/pertuzumab in HER2-positive breast cancer. NPJ Breast Cancer. 2022 May 10;8(1):63. doi: 10.1038/s41523-022-00429-7.
PubMed 35538105
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Non-Randomized Phase II Study of De-escalated Neoadjuvant Chemotherapy With Paclitaxel, Trastuzumab, and Pertuzumab (THP) Compared to Standard Regimen (TCHP) in Patients With Early HER2-Positive Breast Cancer
ClinicalTrials.gov ID: NCT07421141
Acronym / sponsor ID: Opti-HER2 / Opti-HER2-2023
Conditions: Breast Cancer, HER2-positive Breast Cancer, Early Breast Cancer
Keywords: Neoadjuvant Therapy, De-escalation, Paclitaxel, Trastuzumab, Pertuzumab, Pathological Complete Response, THP Regimen
Phase: Phase 2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 186 participants (actual)
Lead sponsor: National Medical Research Radiological Centre of the Ministry of Health of RussiaUniversity, hospital or other
Study start: 1 Sep 2023 (actual)
Primary completion: 10 Dec 2025 (actual)
Study completion: 30 Dec 2028 (estimated)
First posted: 19 Feb 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Background:

Study Design:

This is an investigator-initiated, single-center, open-label, non-randomized phase II study.

Prospective Cohort (n=93): Patients with Stage IIA-IIB (cT1-2 N0-1, cT3 N0) HER2+ breast cancer receive Paclitaxel (80 mg/m2 weekly for 12 weeks) + Trastuzumab (loading 8 mg/kg, then 6 mg/kg q3w) + Pertuzumab (loading 840 mg, then 420 mg q3w).
Historical Control Cohort (n=93): Patients with similar baseline characteristics (Stage IIA-IIB) treated with standard TCHP regimen (Docetaxel 75 mg/m2 + Carboplatin AUC6 + Trastuzumab + Pertuzumab q3w for 6 cycles).

Primary Objective:

To evaluate the pathological complete response (pCR, ypT0/is ypN0) rate in the de-escalated arm.

Secondary Objectives:

To compare the safety profile (incidence of Grade 3-4 adverse events) between THP and TCHP regimens.
To assess the rate of breast-conserving surgery.
To evaluate long-term oncological outcomes (3-year Event-Free Survival).

The study hypothesis is that the de-escalated THP regimen provides a favorable toxicity profile while maintaining high efficacy in a selected population of early HER2+ breast cancer patients.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Prospective single-arm de-escalation cohort compared with a retrospective historical control cohort.

Arm	Type	Receives
Experimental: De-escalated THP	Experimental	Drug: Paclitaxel, Drug: trastuzumab, Drug: Pertuzumab, Procedure: Radical Surgery, Drug: Adjuvant Systemic TherapyPatients receive de-escalated neoadjuvant chemotherapy consisting of 12 weekly cycles of Paclitaxel combined with Trastuzumab and Pertuzumab (THP regimen), followed by surgery.
Historical Control: Standard TCHP	Active comparator	Drug: trastuzumab, Drug: Pertuzumab, Drug: Docetaxel, Drug: carboplatin, Procedure: Radical Surgery, Drug: Adjuvant Systemic TherapyRetrospective cohort of patients who received standard neoadjuvant chemotherapy with Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab (TCHP regimen) for 6 cycles.

Who may qualify

Ages: 18 to 75 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Histologically confirmed invasive breast carcinoma.
HER2-positive status defined as IHC 3+ or FISH amplification (ratio >= 2.0).
Clinical Stage IIA-IIB (cT1-T2 N0-N1, cT3 N0, M0).
Operable disease planned for surgical resection.
ECOG performance status 0-1.

Key exclusion criteria (6 listed)

Metastatic disease (Stage IV).
Prior systemic therapy for breast cancer (chemotherapy, immunotherapy, or anti-HER2 therapy).
Serious cardiac history (congestive heart failure, unstable angina, myocardial infarction within 6 months).
Other synchronous or metachronous malignancies within 5 years (except non-melanoma skin cancer or carcinoma in situ of the cervix).
Pregnancy or breastfeeding.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PaclitaxelAlso: Taxol80 mg/m2 IV weekly for 12 weeks	Drug	Experimental: De-escalated THP
trastuzumabAlso: HerceptinLoading dose 8 mg/kg, then 6 mg/kg IV every 3 weeks	Drug	Experimental: De-escalated THP, Historical Control: Standard TCHP
PertuzumabAlso: PerjetaLoading dose 840 mg, then 420 mg IV every 3 weeks	Drug	Experimental: De-escalated THP, Historical Control: Standard TCHP
DocetaxelAlso: Taxotere75 mg/m2 IV every 3 weeks for 6 cycles	Drug	Historical Control: Standard TCHP
carboplatinAlso: ParaplatinAUC 6 IV every 3 weeks for 6 cycles	Drug	Historical Control: Standard TCHP
Radical SurgeryStandard radical resection (mastectomy or breast-conserving surgery) with axillary staging (sentinel lymph node biopsy and/or axillary lymph node dissection [Levels I-II], according to current clinical guidelines).	Procedure or surgery	Experimental: De-escalated THP, Historical Control: Standard TCHP
Adjuvant Systemic TherapyAlso: Trastuzumab, T-DM1, Trastuzumab EmtansineRisk-adapted post-neoadjuvant treatment based on pathological response: * Patients with pCR (ypT≤1a, ypN0, RCB 0-I) receive Trastuzumab to complete 1 year of anti-HER2 therapy (combined with endocrine therapy for luminal subtypes). * Patients with residual disease (ypT≥1b and/or ypN+ and/or RCB II-III) receive Trastuzumab emtansine (T-DM1) 3.6 mg/kg every 3 weeks for up to 14 cycles (combined with endocrine therapy for luminal subtypes). Adjuvant radiotherapy is administered if clinically indicated.	Drug	Experimental: De-escalated THP, Historical Control: Standard TCHP

Primary outcome

Pathological Complete Response (pCR) Rate
Time frame: At the time of surgery (approximately 12-18 weeks after treatment initiation)
Defined as the absence of invasive cancer in the breast and axillary lymph nodes (ypT0/is ypN0) at the time of surgery

3 secondary outcomes

Incidence of Grade 3-4 Adverse Events
Time frame: From first dose until 30 days after last dose
Rate of Breast-Conserving Surgery
Time frame: At the time of surgery
3-Year Event-Free Survival (EFS)
Time frame: 3 years from enrollment

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
Background: PubMed 28945833Nitz UA, Gluz O, Christgen M, Grischke EM, Augustin D, Kuemmel S, Braun M, Potenberg J, Kohls A, Krauss K, Stefek A, Schumacher C, Forstbauer H, Reimer T, Fischer H, Liedtke C, Wuerstlein R, Schumacher J, Kates R, Kreipe H, Harbeck N. De-escalation strategies in HER2-positive early breast cancer (EBC): final analysis of the WSG-ADAPT HER2+/HR- phase II trial: efficacy, safety, and predictive markers for 12 weeks of neoadjuvant dual blockade with trastuzumab and pertuzumab +/- weekly paclitaxel. Ann Oncol. 2017 Nov 1;28(11):2768-2772. doi: 10.1093/annonc/mdx494.
Background: PubMed 35538105Waks AG, Desai NV, Li T, Poorvu PD, Partridge AH, Sinclair N, Spring LM, Faggen M, Constantine M, Metzger O, Alberti J, Deane J, Rosenberg SM, Frank E, Tolaney SM, Krop IE, Tung NM, Tayob N, King TA, Mittendorf EA, Winer EP. A prospective trial of treatment de-escalation following neoadjuvant paclitaxel/trastuzumab/pertuzumab in HER2-positive breast cancer. NPJ Breast Cancer. 2022 May 10;8(1):63. doi: 10.1038/s41523-022-00429-7.
Background: PubMed 23704196Schneeweiss 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.
Individual participant dataSharing planned: No. Individual participant data will not be shared due to patient confidentiality requirements

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Larisa Bolotina, MD, PhD principal investigator

P.A. Hertsen Moscow Oncology Research Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological Complete Response (pCR) Rate (time frame: At the time of surgery (approximately 12-18 weeks after treatment initiation)). 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 NCT07421141, which also lists 3 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 27 Feb 2026.