HER2-positive Breast CancerPhase 2ELPISNCT04578106
Omission of Surgery in Clinically Low-risk HER2positive Breast Cancer With High HER2 Addiction and a Complete Response Following Standard Anti-HER2-based Neoadjuvant Therapy
A Phase 2 study testing Trastuzumab and pertuzumab Subcutaneous Fixed-Dose Combination in people with HER2-positive Breast Cancer and Stage I Breast Cancer, run by Fundacio Clinic Barcelona at 1 site in Spain.
Trial summary
This is a prospective, single arm, open-label, unicenter, exploratory study in women with primary operable HER2-positive, HER2-enriched/ERBB2-high breast cancer according to PAM50 intrinsic subtype and a ERBB2 pre-defined cutoff (high vs low ERBB2 expression), to evaluate the omission of surgery and sentinel lymph… Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- HER2-positive Breast Cancer, Stage I Breast Cancer
- What is being tested?
- Trastuzumab and pertuzumab Subcutaneous Fixed-Dose Combination
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteSpain
- Study dates
- 23 Sep 2020to 16 Jul 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female participants who are at least 40 years of age on the day of signing the informed consent form with histologically confirmed diagnosis of breast cancer.
- A participant is eligible to participate if she is not pregnant, not breastfeeding.
- The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
- Histologically confirmed invasive adenocarcinoma of the breast, with all of the following characteristics:
- HER2-positive status by local determination according to 2018 ASCO/CAP guidelines.
- PAM50 HER2-enriched subtype and ERBB2-high as predefined cutoff as per central determination.
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- Unifocal invasive carcinoma: only 1 invasive focus can be observed (the tumor focus containing or not containing an in situ component)
- Tumor largest diameter ≤4 cm as defined by breast MRI.
- No nodal involvement (i.e. cN0). Any suspicious axillary node by ultrasound must be biopsied. If the biopsy or the FNA is negative of tumor cells, patient is eligible.
- No evidence of distant metastasis (M0) by routine clinical assessment.
- Patient must have known ER and PR status locally determined prior to study entry.
- Eligible for taxane therapy.
- Willingness of the patient to omit surgery if all criteria are met following neoadjuvant therapy.
- Estimated life expectancy of at least 5 years irrespective of the diagnosis of breast cancer.
- Breast cancer eligible for primary surgery
- Have provided archival tumor tissue sample or newly obtained core. Formalin-fixed,paraffin embedded (FFPE) tissue blocks are mandatory. Available pre-treatment FFPE core biopsy evaluable for PAM50 or possibility to obtain one.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Ability and willingness to comply with study visits, treatment, testing and to comply with the protocol.
- Have adequate organ function.
Who cannot join
- Has received prior anti-cancer therapy, including investigational agents, or treatment for primary invasive breast cancer.
- Known hypersensitivity to any of the excipients of trastuzumab, pertuzumab, TDM1 or paclitaxel.
- Clinical stage II, III or IV.
- History of radiotherapy in the ipsilateral breast or axilla.
- History of surgery of the ipsilateral axilla.
- Bilateral invasive breast cancer.
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- Infiltrating lobular carcinoma.
- Multicentric or multifocal breast cancer, defined as the presence of two or more foci of cancer in the same or different quadrants of the same breast.
- Patients who have undergone sentinel lymph node biopsy prior to study treatment.
- Patient has active cardiac disease or a history of cardiac dysfunction
- Has an active infection requiring systemic therapy.
- 13. Patients with a history of previous breast cancer are excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Omission of Surgery and Sentinel Lymph Node Dissection in Clinically Low-risk HER2positive Breast Cancer With High HER2 Addiction and a Complete Response Following Standard Anti-HER2-based Neoadjuvant Therapy
This is a prospective, single arm, open-label, unicenter, exploratory study in women with primary operable HER2-positive, HER2-enriched/ERBB2-high breast cancer according to PAM50 intrinsic subtype and a ERBB2 pre-defined cutoff (high vs low ERBB2 expression), to evaluate the omission of surgery and sentinel lymph node dissection in patients with HER2-E and ERBB2 high breast cancer who achieving a complete response following standard anti-HER2-based neoadjuvant therapy with paclitaxel/trastuzumab/pertuzumab. The primary trial objective is to estimate the loco-regional invasive disease-free survival at 3-year of patients who achieve a complete response based on imaging (i.e. Magnetic resonance imaging) and a stereotactic-guided vacuum-assisted breast biopsy, and omit loco-regional surgery.
- Conditions
- HER2-positive Breast Cancer, Stage I Breast Cancer
- Being tested
- Trastuzumab and pertuzumab Subcutaneous Fixed-Dose Combination
- Keywords
- Breast Cancer, Her2-positive, Pertuzumab, Trastuzumab, Omission surgery
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trastuzumab and pertuzumab Subcutaneous Fixed-Dose CombinationBiological
Also called Omission of surgery
After 13 weeks of neoadjuvant treatment, a breast MRI will be performed. If a complete response is observed on breast MRI, patients will undergo a stereotactic-guided VAB of the marker area to obtain 12 cylinders of breast parenchyma, which is equivalent to 2 grams of tissue. If no invasive tumor cells and no in situ disease are identified in the stereotactic-guided VAB, patients will be eligible to omit loco-regional surgery.
| Study group | Role | What they receive |
|---|---|---|
| Omission of surgery | Experimental | Neoadjuvant period: paclitaxel IV 80mg/m2 every week for 12 weeks with trastuzumab and pertuzumab Subcutaneous Fixed-Dose Combination (FDC) (a loading dose of 1200 mg pertuzumab and 600 mg trastuzumab followed by a maintenance dose of 600 mg pertuzumab and 600 mg trastuzumab once every 3 weeks) for 5 cycles. Adjuvant period: If no invasive tumor cells and no in situ disease are identified in the stereotactic-guided VAB,patients will be eligible to omit loco-regional surgery. Whole breast radiotherapy without nodal radiotherapy will then be performed. Trastuzumab and pertuzumab FDC will be continued to complete 1 year of treatment and adjuvant endocrine therapy will be indicated according to hormonal receptor status by IHC. Receives: Biological: Trastuzumab and pertuzumab Subcutaneous Fixed-Dose Combination |
| Surgery | No intervention | Neoadjuvant period: paclitaxel IV 80mg/m2 every week for 12 weeks with trastuzumab and pertuzumab Subcutaneous Fixed-Dose Combination (FDC) (a loading dose of 1200 mg pertuzumab and 600 mg trastuzumab followed by a maintenance dose of 600 mg pertuzumab and 600 mg trastuzumab once every 3 weeks) for 5 cycles. Surgery: If invasive tumor cells and/or in situ disease are identified, patients will undergo surgery. Adjuvant period: All patients will continue with Trastuzumab-emtansine (T-DM1) completing 1 year of treatment (14 cycles) and adjuvant endocrine therapy will be indicated according to hormonal receptor status by IHC. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free Survival at 3years
To estimate the loco-regional invasive disease-free survival (LR-IDFS) at 3-year of patients who achieve a complete response based on imaging and a stereotactic-guided vacuum-assisted breast biopsy, and omit loco-regional surgery.
Measured: 3 years
Secondary outcomes (2)
pCR Rate
rate of pathological complete response (pCR) between the treatment groups by HR status
Measured: pCR assessment was done following surgery after neoadjuvant therapy with paclitaxel and trastuzumzb/pertuzumab prior to adjuvant therapy
Patient Reported Outcomes (Global Health Status)
The EORTC QLQ-C30 was used to assess Health-Related Quality of Life (QoL). The measure consists of five functional scales (physical, role, cognitive, emotional, and social). For this study, raw scores were used without any transformation. The functional scales consist of multiple items (questions 1-28) scored on a 1-4 scale (1 = not at all, 4 = very much). Higher scores indicate worse functioning. To assess the effect of standard therapy (surgery after neoadjuvant therapy) vs. investigational therapy (omission of surgery), the global health status is reported in each of these populations before and after treatment.
The Global Health Status (GHS) score is derived from two items (Q29 and Q30), each scored on a 1-7 scale (1 = very poor, 7 = excellent).
Scoring method: GHS = (Q29 + Q30) / 2 Raw score range: Minimum = (1 + 1) / 2 = 1; Maximum = (7 + 7) /2 = 7
Measured: The questionnaire was filled by the patients at screening and post adjuvant therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start23 Sep 2020
- Primary completion16 Jul 2024
- Study completion16 Jul 2024
Why it stopped: The study was prematurely halted primarily due to low patient accrual. Despite efforts to optimize recruitment, the enrollment rate remained insufficient to meet the predefined targets, and continuation was deemed unfeasible
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HER2-positive 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
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio Clinic Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- SOLTI Breast Cancer Research Group, Roche Pharma AG
- Responsible party
- Sponsor
- Investigators
- Aleix Prat, MD, Principal investigator, Hospital Clinic of BarcelonaTomas Pascual, MD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04578106
- Sponsor's protocol ID
- HCB-ONC001 (ML41519)
- Acronym
- ELPIS
- Status last verified
- Jan 2026
- First submitted
- 29 Sep 2020
- Last updated
- 6 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omission of Surgery and Sentinel Lymph Node Dissection in Clinically Low-risk HER2positive Breast Cancer With High HER2 Addiction and a Complete Response Following Standard Anti-HER2-based Neoadjuvant Therapy
- ClinicalTrials.gov ID
- NCT04578106
- Acronym / sponsor ID
- ELPIS / HCB-ONC001 (ML41519)
- Conditions
- HER2-positive Breast Cancer, Stage I Breast Cancer
- Keywords
- Breast Cancer, Her2-positive, Pertuzumab, Trastuzumab, Omission surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was prematurely halted primarily due to low patient accrual. Despite efforts to optimize recruitment, the enrollment rate remained insufficient to meet the predefined targets, and continuation was deemed unfeasible
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Fundacio Clinic BarcelonaUniversity, hospital or other
- Collaborators
- SOLTI Breast Cancer Research Group, Roche Pharma AG
- Study start
- 23 Sep 2020 (actual)
- Primary completion
- 16 Jul 2024 (actual)
- Study completion
- 16 Jul 2024 (actual)
- First posted
- 8 Oct 2020 (actual)
- Results
- Posted 6 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, single arm, open-label, unicenter, exploratory study in women with primary operable HER2-positive, HER2-enriched/ERBB2-high breast cancer according to PAM50 intrinsic subtype and a ERBB2 pre-defined cutoff (high vs low ERBB2 expression), to evaluate the omission of surgery and sentinel lymph node dissection in patients with HER2-E and ERBB2 high breast cancer who achieving a complete response following standard anti-HER2-based neoadjuvant therapy with paclitaxel/trastuzumab/pertuzumab. The primary trial objective is to estimate the loco-regional invasive disease-free survival at 3-year of patients who achieve a complete response based on imaging (i.e. Magnetic resonance imaging) and a stereotactic-guided vacuum-assisted breast biopsy, and omit loco-regional surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omission of surgery | Experimental | Biological: Trastuzumab and pertuzumab Subcutaneous Fixed-Dose CombinationNeoadjuvant period: paclitaxel IV 80mg/m2 every week for 12 weeks with trastuzumab and pertuzumab Subcutaneous Fixed-Dose Combination (FDC) (a loading dose of 1200 mg pertuzumab and 600 mg trastuzumab followed by a maintenance dose of 600 mg pertuzumab and 600 mg trastuzumab once every 3 weeks) for 5 cycles. Adjuvant period: If no invasive tumor cells and no in situ disease are identified in the stereotactic-guided VAB,patients will be eligible to omit loco-regional surgery. Whole breast radiotherapy without nodal radiotherapy will then be performed. Trastuzumab and pertuzumab FDC will be continued to complete 1 year of treatment and adjuvant endocrine therapy will be indicated according to hormonal receptor status by IHC. |
| Surgery | No intervention | –Neoadjuvant period: paclitaxel IV 80mg/m2 every week for 12 weeks with trastuzumab and pertuzumab Subcutaneous Fixed-Dose Combination (FDC) (a loading dose of 1200 mg pertuzumab and 600 mg trastuzumab followed by a maintenance dose of 600 mg pertuzumab and 600 mg trastuzumab once every 3 weeks) for 5 cycles. Surgery: If invasive tumor cells and/or in situ disease are identified, patients will undergo surgery. Adjuvant period: All patients will continue with Trastuzumab-emtansine (T-DM1) completing 1 year of treatment (14 cycles) and adjuvant endocrine therapy will be indicated according to hormonal receptor status by IHC. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Female participants who are at least 40 years of age on the day of signing the informed consent form with histologically confirmed diagnosis of breast cancer.
- A participant is eligible to participate if she is not pregnant, not breastfeeding.
- The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
- Histologically confirmed invasive adenocarcinoma of the breast, with all of the following characteristics:
- Patient must have known ER and PR status locally determined prior to study entry.
Key exclusion criteria (12 listed)
- Has received prior anti-cancer therapy, including investigational agents, or treatment for primary invasive breast cancer.
- Known hypersensitivity to any of the excipients of trastuzumab, pertuzumab, TDM1 or paclitaxel.
- Clinical stage II, III or IV.
- History of radiotherapy in the ipsilateral breast or axilla.
- History of surgery of the ipsilateral axilla.
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 |
|---|---|---|
| Trastuzumab and pertuzumab Subcutaneous Fixed-Dose CombinationAlso: Omission of surgeryAfter 13 weeks of neoadjuvant treatment, a breast MRI will be performed. If a complete response is observed on breast MRI, patients will undergo a stereotactic-guided VAB of the marker area to obtain 12 cylinders of breast parenchyma, which is equivalent to 2 grams of tissue. If no invasive tumor cells and no in situ disease are identified in the stereotactic-guided VAB, patients will be eligible to omit loco-regional surgery. | Biological | Omission of surgery |
Primary outcome
Disease-free Survival at 3years
Time frame: 3 years
To estimate the loco-regional invasive disease-free survival (LR-IDFS) at 3-year of patients who achieve a complete response based on imaging and a stereotactic-guided vacuum-assisted breast biopsy, and omit loco-regional surgery.
2 secondary outcomes
pCR Rate
Time frame: pCR assessment was done following surgery after neoadjuvant therapy with paclitaxel and trastuzumzb/pertuzumab prior to adjuvant therapy
Patient Reported Outcomes (Global Health Status)
Time frame: The questionnaire was filled by the patients at screening and post adjuvant therapy.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Aleix Prat, MD principal investigator
Hospital Clinic of Barcelona
Tomas Pascual, MD principal investigator
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trastuzumab and pertuzumab Subcutaneous Fixed-Dose Combination in people with HER2-positive Breast Cancer and Stage I Breast Cancer, run by Fundacio Clinic Barcelona at 1 site in Spain.
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 19 inclusion and 12 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: stopped early, as of the sponsor's last update on 6 Jan 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 Spain. 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?
Yes. Results are posted in the registry (first posted 6 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Disease-free Survival at 3years (time frame: 3 years). 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 6 Jan 2026.