Breast Cancer - Infiltrating Ductal CarcinomaPhase 2NCT07506876
Concurrent Neoadjuvant Chemo/Endocrine Therapy in HER2+ Breast Cancer
A Phase 2 study testing Concurrent endocrine therapy with the chemotherapy and HER2 directed therapy in people with Breast Cancer - Infiltrating Ductal Carcinoma and HER-2 Positive Breast Cancer, run by Legacy Health System at 4 sites in United States.
Trial summary
The usual approach to care for hormone receptor positive, HER2 positive breast cancer is chemotherapy and HER2 targeted therapy followed by endocrine therapy and surgery. The purpose of this Research Study is to see if taking endocrine therapy with the chemotherapy and HER2 directed therapy increases patients response… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer - Infiltrating Ductal Carcinoma, HER-2 Positive Breast Cancer
- What is being tested?
- Concurrent endocrine therapy with the chemotherapy and HER2 directed therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesUnited States
- Study dates
- 27 Apr 2026to Dec 2027
- 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
- Adults over 18 years of age with newly diagnosed, previously untreated, HR+, HER2+ breast cancer (positive per local guidelines)
- Endocrine therapy for the current breast cancer may be started within 28 days prior to trial enrollment and must be initiated prior to C2 of chemotherapy/HER2 directed therapy
- Choice of endocrine therapy will be determined by the treating and/or enrolling physician
- Anatomic Stage IIA - IIIC breast cancer planning a minimum of 4 cycles of TCHP
- Patients must be Luminal A, Luminal B or HER2 enriched subtype on MammaPrint/BluePrint performed on initial biopsy
Who cannot join
- Children under 18 years of age, pregnant women, prisoners, and decisionally impaired adults.
- Patients with non-breast cancer within prior 2 years
- Patients with breast cancer within prior 5 years
- Patients with recurrent breast cancer
- Patients with stage IV breast cancer
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Legacy Mount Hood Medical Center
Gresham, Oregon, 97030
Legacy Oncology Clinical Research, 503-13-8199, oncologyresearch@lhs.org
- Recruiting
Legacy Good Samaritan Medical Center
Portland, Oregon, 97210
Legacy Oncology Research, 503-413-8199, oncologyresearch@lhs.org
- Recruiting
Legacy Meridian Park Medical Center
Tualatin, Oregon, 97062
Legacy Oncology Clinical Research, 503-413-8199, oncologyresearch@lhs.org
- Recruiting
Legacy Salmon Creek Medical Center
Vancouver, Washington, 98686
Legacy Oncology Clinical Research, 503-413-8199, oncologyresearch@lhs.org
About this study
The usual approach to care for hormone receptor positive, HER2 positive breast cancer is chemotherapy and HER2 targeted therapy followed by endocrine therapy and surgery.
The purpose of this Research Study is to see if taking endocrine therapy with the chemotherapy and HER2 directed therapy increases patients response to therapy at the time of surgery
- Being tested
- Concurrent endocrine therapy with the chemotherapy and HER2 directed therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concurrent endocrine therapy with the chemotherapy and HER2 directed therapyDrug
Concurrent endocrine therapy with the chemotherapy and HER2 directed therapy
| Study group | Role | What they receive |
|---|---|---|
| Concurrent endocrine therapy with the chemotherapy and HER2 directed therapy | Experimental | Not described Receives: Drug: Concurrent endocrine therapy with the chemotherapy and HER2 directed therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR Rates
To estimate the rates of pCR in patients receiving neoadjuvant chemotherapy combined with HER2 directed therapy and concurrent endocrine therapy, compared with matched historical controls who received neoadjuvant chemotherapy and HER2 directed therapy alone, stratified by molecularly determined Luminal versus HER2 enriched subtypes
Measured: 21 months
Secondary outcomes (1)
RCB scores
To compare the distribution of RCB scores and nodal clearance rates between the two treatment groups and across the two molecular subtypes.
Measured: 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start27 Apr 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer - Infiltrating Ductal CarcinomaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Legacy Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nathalie Johnson, Legacy Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07506876
- Sponsor's protocol ID
- 50876
- Status last verified
- Apr 2026
- First submitted
- 26 Mar 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concurrent Neoadjuvant Chemo/Endocrine Therapy in HER2+ Breast Cancer
- ClinicalTrials.gov ID
- NCT07506876
- Acronym / sponsor ID
- 50876
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Legacy Health SystemUniversity, hospital or other
- Study start
- 27 Apr 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 2 Apr 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.
The usual approach to care for hormone receptor positive, HER2 positive breast cancer is chemotherapy and HER2 targeted therapy followed by endocrine therapy and surgery.
The purpose of this Research Study is to see if taking endocrine therapy with the chemotherapy and HER2 directed therapy increases patients response to therapy at the time of surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Concurrent endocrine therapy with the chemotherapy and HER2 directed therapy | Experimental | Drug: Concurrent endocrine therapy with the chemotherapy and HER2 directed therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults over 18 years of age with newly diagnosed, previously untreated, HR+, HER2+ breast cancer (positive per local guidelines)
- Anatomic Stage IIA - IIIC breast cancer planning a minimum of 4 cycles of TCHP
- Patients must be Luminal A, Luminal B or HER2 enriched subtype on MammaPrint/BluePrint performed on initial biopsy
Key exclusion criteria (5 listed)
- Children under 18 years of age, pregnant women, prisoners, and decisionally impaired adults.
- Patients with non-breast cancer within prior 2 years
- Patients with breast cancer within prior 5 years
- Patients with recurrent breast cancer
- Patients with stage IV breast cancer
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 |
|---|---|---|
| Concurrent endocrine therapy with the chemotherapy and HER2 directed therapyConcurrent endocrine therapy with the chemotherapy and HER2 directed therapy | Drug | Concurrent endocrine therapy with the chemotherapy and HER2 directed therapy |
Primary outcome
pCR Rates
Time frame: 21 months
To estimate the rates of pCR in patients receiving neoadjuvant chemotherapy combined with HER2 directed therapy and concurrent endocrine therapy, compared with matched historical controls who received neoadjuvant chemotherapy and HER2 directed therapy alone, stratified by molecularly determined Luminal versus HER2 enriched subtypes
1 secondary outcome
RCB scores
Time frame: 21 months
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 1 May 2026.
- Individual participant dataSharing planned: No
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Concurrent endocrine therapy with the chemotherapy and HER2 directed therapy in people with Breast Cancer - Infiltrating Ductal Carcinoma and HER-2 Positive Breast Cancer, run by Legacy Health System at 4 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 5 inclusion and 5 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 1 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 4 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCR Rates (time frame: 21 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 May 2026.