HER2-positive Breast CancerPhase 2NCT04419181
Feasibility of Chemotherapy De-escalation in Early-Stage HER2 Positive Breast Cancer
A Phase 2 study testing Docetaxel, Carboplatin and Trastuzumab in people with HER2-positive Breast Cancer, run by University of Rochester at 1 site in United States.
Trial summary
The main purpose of this research study is to find out if de-escalation of chemotherapy before surgery followed by a selective escalation of adjuvant targeted therapies are efficacious and tolerable in early-stage HER2 positive breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HER2-positive Breast Cancer
- What is being tested?
- Docetaxel, Carboplatin and Trastuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2025to 1 Jun 2027
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women ≥18 years of age
- Biopsy proven HER2+ early breast cancer
- ECOG performance status 0-1
- Should be a candidate for neoadjuvant chemotherapy using standard guidelines of tumor size of 2cm or more and /or axillary lymph node-positive disease.
- Adequate cardiac, bone marrow, kidney, and liver functions per treating physician's discretion.
- Women of childbearing potential who are sexually active must agree to use highly effective methods of contraception during treatment and for three weeks after the last dose of chemotherapy or anti-HER2 therapy. The women currently using hormonal contraceptives must agree to change to an alternative highly effective method of contraception
- Willingness and ability to comply with study and follow-up procedures and give written informed consent.
Who cannot join
- Any evidence of stage IV breast cancer
- Participant deemed unsuitable for clinical trial enrolment by treating physician based on the participants' compliance, location and commute requirements, or tolerance of therapies involved
- Any invasive malignancy within the last two years of study enrollment except for adequately treated basal cell carcinoma, squamous cell carcinoma, or non-melanoma skin cancer.
- Women who are pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: A Feasibility Study of De-escalation of Chemotherapy in Patients With Early-Stage HER2 Positive Breast Cancer
The main purpose of this research study is to find out if de-escalation of chemotherapy before surgery followed by a selective escalation of adjuvant targeted therapies are efficacious and tolerable in early-stage HER2 positive breast cancer.
Read the detailed description
Assess the feasibility of four cycles of neoadjuvant Docetaxel Carboplatin Trastuzumab and Pertuzumab (TCHP) in women with early-stage (local/locally advanced) HER2+ breast cancer with a selective escalation of targeted HER2 directed therapy in the high risk group in the adjuvant setting. Participants with any residual disease after four cycles of TCHP will receive Trastuzumab Emtansine (TDM1) plus Pertuzumab while those with complete pathological response will receive Trastuzumab in the adjuvant settings.
- Conditions
- HER2-positive Breast Cancer
- Being tested
- Docetaxel, Carboplatin, Trastuzumab, Pertuzumab, Trastuzumab emtansine
- Keywords
- HER2-positive Breast Cancer, De-escalation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Also called Taxotere
Dose: 75 mg/m2 q3w
CarboplatinDrug
Also called Paraplatin
Dose: area under the concentration-time curve [AUC] 6 q3w
TrastuzumabDrug
Also called Herceptin
Dose: 8-mg/kg loading dose, 6-mg/kg maintenance dose q3w
PertuzumabDrug
Also called Perjeta
Dose: 840-mg loading dose, 420-mg maintenance dose q3w
Trastuzumab emtansineDrug
Also called TDM1
Dose: 3.6mg/kg q3w
| Study group | Role | What they receive |
|---|---|---|
| Pathologic complete response (pCR) | Experimental | Participants will receive four cycles of TCHP [docetaxel (Taxotere®), carboplatin, trastuzumab (Herceptin®), pertuzumab], followed by surgery. Participants who achieve pathologic complete response will receive infusions of trastuzumab every 3 weeks for a total of 12 cycles/infusions. Receives: Drug: Docetaxel; Drug: Carboplatin; Drug: Trastuzumab; Drug: Pertuzumab |
| Residual Disease | Experimental | Participants will receive four cycles of TCHP [docetaxel (Taxotere®, carboplatin, trastuzumab (Herceptin®), pertuzumab], followed by surgery. Participants who have residual disease may be offered two more cycles of TCHP in the adjuvant settings (optional) per treating oncologist's discretion and then will receive infusion of Trastuzumab Emtansine (TDM1) plus pertuzumab every three weeks for a total of 12 cycles/infusions. Receives: Drug: Docetaxel; Drug: Carboplatin; Drug: Trastuzumab; Drug: Pertuzumab; Drug: Trastuzumab emtansine |
What is being measured
The primary outcome is the main question the study is designed to answer.
One Year Invasive Disease-Free Survival
The study will be considered feasible if the researchers observe the invasive disease free survival (IDFS) estimate at one year to be 90% or more among those who achieved a pCR, or if the researchers observe the IDFS estimate at one year to be 85% or more among those who had residual disease.
Measured: One year from the breast cancer surgery
Secondary outcomes (3)
Pathologic Complete Response rate
Assess the pCR rate after four cycles (12 weeks) of TCHP.
Measured: 12 weeks from start of treatment
Toxicity of chemo and HER2 therapies
Evaluate toxicity associated with neoadjuvant and adjuvant chemo and/or HER2 directed therapies. Percentage of grade 1 to grade 5 toxicities will be assessed during the neo-adjuvant TCHP therapy for all participants. Percentage of grade 1 to grade 5 toxicities will be assessed with adjuvant trastuzumab therapy for the cohort with pathological complete response, and with optional adjuvant TCHP therapy and adjuvant TDM1 + pertuzumab therapy for the residual disease cohort. Toxicity data will be obtained based on the clinical assessment of the participants by the investigators and based on laboratory data.
Measured: One year from the start of treatment
Two Year Invasive Disease-Free Survival
Two year invasive disease-free survival (IDFS) of participants with pCR and participants with residual disease
Measured: Two years from the breast cancer surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start11 Aug 2025 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Why it stopped: Change in the landscape of current treatment of early stage breast cancer. Larger clinical trials answering similar questions are expected to result in the next few years.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Breast CancerStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- 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
- Participants will be assigned to an arm of the trial based on their outcomes after surgery.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ajay Dhakal, University of Rochester
- Investigators
- Ajay Dhakal, MBBS, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04419181
- Sponsor's protocol ID
- UBRS20013
- Status last verified
- Oct 2025
- First submitted
- 1 Jun 2020
- Last updated
- 14 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of De-escalation of Chemotherapy in Patients With Early-Stage HER2 Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT04419181
- Acronym / sponsor ID
- UBRS20013
- Conditions
- HER2-positive Breast Cancer
- Keywords
- HER2-positive Breast Cancer, De-escalation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change in the landscape of current treatment of early stage breast cancer. Larger clinical trials answering similar questions are expected to result in the next few years.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 11 Aug 2025 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 5 Jun 2020 (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 main purpose of this research study is to find out if de-escalation of chemotherapy before surgery followed by a selective escalation of adjuvant targeted therapies are efficacious and tolerable in early-stage HER2 positive breast cancer.
Detailed description
Assess the feasibility of four cycles of neoadjuvant Docetaxel Carboplatin Trastuzumab and Pertuzumab (TCHP) in women with early-stage (local/locally advanced) HER2+ breast cancer with a selective escalation of targeted HER2 directed therapy in the high risk group in the adjuvant setting. Participants with any residual disease after four cycles of TCHP will receive Trastuzumab Emtansine (TDM1) plus Pertuzumab while those with complete pathological response will receive Trastuzumab in the adjuvant settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be assigned to an arm of the trial based on their outcomes after surgery.
| Arm | Type | Receives |
|---|---|---|
| Pathologic complete response (pCR) | Experimental | Drug: Docetaxel, Drug: Carboplatin, Drug: Trastuzumab, Drug: PertuzumabParticipants will receive four cycles of TCHP [docetaxel (Taxotere®), carboplatin, trastuzumab (Herceptin®), pertuzumab], followed by surgery. Participants who achieve pathologic complete response will receive infusions of trastuzumab every 3 weeks for a total of 12 cycles/infusions. |
| Residual Disease | Experimental | Drug: Docetaxel, Drug: Carboplatin, Drug: Trastuzumab, Drug: Pertuzumab, Drug: Trastuzumab emtansineParticipants will receive four cycles of TCHP [docetaxel (Taxotere®, carboplatin, trastuzumab (Herceptin®), pertuzumab], followed by surgery. Participants who have residual disease may be offered two more cycles of TCHP in the adjuvant settings (optional) per treating oncologist's discretion and then will receive infusion of Trastuzumab Emtansine (TDM1) plus pertuzumab every three weeks for a total of 12 cycles/infusions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Women ≥18 years of age
- Biopsy proven HER2+ early breast cancer
- ECOG performance status 0-1
- Should be a candidate for neoadjuvant chemotherapy using standard guidelines of tumor size of 2cm or more and /or axillary lymph node-positive disease.
- Adequate cardiac, bone marrow, kidney, and liver functions per treating physician's discretion.
Key exclusion criteria (4 listed)
- Any evidence of stage IV breast cancer
- Participant deemed unsuitable for clinical trial enrolment by treating physician based on the participants' compliance, location and commute requirements, or tolerance of therapies involved
- Any invasive malignancy within the last two years of study enrollment except for adequately treated basal cell carcinoma, squamous cell carcinoma, or non-melanoma skin cancer.
- Women who are pregnant 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 |
|---|---|---|
| DocetaxelAlso: TaxotereDose: 75 mg/m2 q3w | Drug | Pathologic complete response (pCR), Residual Disease |
| CarboplatinAlso: ParaplatinDose: area under the concentration-time curve [AUC] 6 q3w | Drug | Pathologic complete response (pCR), Residual Disease |
| TrastuzumabAlso: HerceptinDose: 8-mg/kg loading dose, 6-mg/kg maintenance dose q3w | Drug | Pathologic complete response (pCR), Residual Disease |
| PertuzumabAlso: PerjetaDose: 840-mg loading dose, 420-mg maintenance dose q3w | Drug | Pathologic complete response (pCR), Residual Disease |
| Trastuzumab emtansineAlso: TDM1Dose: 3.6mg/kg q3w | Drug | Residual Disease |
Primary outcome
One Year Invasive Disease-Free Survival
Time frame: One year from the breast cancer surgery
The study will be considered feasible if the researchers observe the invasive disease free survival (IDFS) estimate at one year to be 90% or more among those who achieved a pCR, or if the researchers observe the IDFS estimate at one year to be 85% or more among those who had residual disease.
3 secondary outcomes
Pathologic Complete Response rate
Time frame: 12 weeks from start of treatment
Toxicity of chemo and HER2 therapies
Time frame: One year from the start of treatment
Two Year Invasive Disease-Free Survival
Time frame: Two years from the breast cancer surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2025.
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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.
Ajay Dhakal, MBBS principal investigator
University of Rochester
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 Docetaxel, Carboplatin and Trastuzumab in people with HER2-positive Breast Cancer, run by University of Rochester at 1 site 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 7 inclusion and 4 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: withdrawn, as of the sponsor's last update on 14 Oct 2025. 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
One Year Invasive Disease-Free Survival (time frame: One year from the breast cancer surgery). 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 14 Oct 2025.