Breast CancerPhase 1NCT03716180

DAPHNe: Paclitaxel/Trastuzumab/Pertuzumab in HER2-Positive BC

A Phase 1 study testing Paclitaxel, Trastuzumab and Pertuzumab in people with Breast Cancer, run by Dana-Farber Cancer Institute at 5 sites in United States.

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 research study is studying whether participants and their doctors are willing to determine post-surgery treatment on the basis of response to pre-surgery treatment, and studying blood and tissue collected from participants treated with a combination of drugs as a treatment for 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?: Paclitaxel, Trastuzumab and Pertuzumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 5 sitesUnited States
Study dates: 5 Nov 2018to 1 Sep 2030
Phase: Phase 1
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

Patients must have Stage II or III (according to AJCC cancer staging manual anatomic staging table, 8th edition) histologically confirmed invasive carcinoma of the breast. A minimum tumor size of 1.5 cm determined by physical exam or imaging (whichever is larger) is required. Patients with inflammatory breast carcinoma (T4d) are NOT eligible.
Tumors must be HER-2 positive, as assessed by standard local institutional protocol (central testing is not required):
IHC 3+
FISH positive based on one of the three following criteria:
Single-probe average HER2 copy number ≥ 6.0 signals/cell; OR
Dual-probe HER2/CEP17 ratio <2.0 with an average HER2 copy number ≥ 6.0 signals/cell; OR

Show all 27Show fewer

Dual-probe HER2/CEP17 ratio ≥2.0
ER/PR determination is required. ER- and PR-assays should be performed by immunohistochemical methods according to the local institution standard protocol.
Bilateral breast cancers are allowed as long as both cancers are HER2-positive (as defined in 3.1.2), or the contralateral cancer is a <1 cm, ER+, and HER2- tumor.
Patients with multifocal or multicentric disease are eligible as long as all tumor foci that were tested for HER2 status at the local institution are HER2-positive, and at least one tumor focus meets eligibility criteria.
Breast imaging should include dedicated ultrasound of the ipsilateral axilla. For subjects with a clinically positive axilla based on exam or imaging, a fine needle aspiration or core biopsy procedure will be performed to determine the presence of metastatic disease in the lymph nodes (though lymph node sampling procedure need not be resulted prior to patient's registration on trial, as long as all other eligibility are met).
Men and women (with any menopausal status) ≥ 18 years of age are eligible.
ECOG PS 0 or 1.
Required laboratory values:
ANC ≥ 1000/mm3
Hemoglobin ≥ 9 g/dl
Platelets ≥ 100,000/mm3
Serum creatinine < 1.5 x ULN (institutional) OR calculated GFR ≥60mL/min.
-Total bilirubin ≤ 1.5 x ULN (institutional). For patients with Gilbert Syndrome, the direct bilirubin should be within the institutional normal range OR total bilirubin ≤ 2.0 mg/dL.
AST and ALT ≤ 2.5x ULN (institutional)
Left ventricular ejection fraction (LVEF) ≥ 50%.
Premenopausal women must have a negative serum pregnancy test within 14 days of registration, including women who have had a tubal ligation and for women less than 12 months after the onset of menopause.
Women of childbearing potential and men with partners of childbearing potential must be willing to use one highly effective form of non-hormonal contraception or two effective forms of non-hormonal contraception by the patient and/or partner and continue its use for the duration of the study treatment and for 7 months after the last dose of study treatment.
Patients with a history of ipsilateral DCIS are eligible.
Patients undergoing breast conservation therapy (i.e. lumpectomy) must not have any contraindications to radiation therapy.
Willing and able to sign informed consent.
Willing to provide tissue for research purposes

Who cannot join

Pregnant or nursing women due to the teratogenic potential of the study drugs.
Active, unresolved infection.
Receipt of intravenous antibiotics for infection within 7 days prior to registration.
Uncontrolled hypertension (systolic >180 mm Hg and/or diastolic >100 mm Hg) or clinically significant (i.e. active) cardiovascular disease: cerebrovascular accident/stroke or myocardial infarction within 6 months prior to first study medication, unstable angina, congestive heart failure (CHF) of New York Heart Association (NYHA) Class II or higher (see Appendix B), or serious cardiac arrhythmia requiring medication.
Significant symptoms (Grade ≥ 2) from peripheral neuropathy.
Other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness, uncontrolled infections, uncontrolled diabetes.
Any prior treatment for the current breast cancer, including chemotherapy, hormonal therapy, radiation, or experimental therapy

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
DF/BWCC at Milford Regional Medical Center
Milford, Massachusetts, 01757
DF/BWCC in clinical affiliation with South Shore Hospital
South Weymouth, Massachusetts, 02190

Other trials in United States

About this study

Official title: DAPHNe: De-escalation to Adjuvant Antibodies Post-pCR to Neoadjuvant THP (Paclitaxel/Trastuzumab/Pertuzumab)-a Pilot Study in HER2-positive Breast Cancer

The names study drugs involved in this study are:

Paclitaxel (also called Taxol)
Trastuzumab (also called Herceptin)
Pertuzumab (also called Perjeta)

Read the detailed description

This research study is a Pilot Study, which means investigators are looking at the feasibility of a new approach for deciding the optimal medical treatment for this type of breast cancer. The FDA (the U.S. Food and Drug Administration) has approved paclitaxel, trastuzumab, and pertuzumab as part of a pre-operative treatment option for this disease.

The purpose of this study is to evaluate whether participants and their doctors are willing to accept a treatment recommendation for post-operative chemotherapy, on the basis of the participant's response to pre-operative treatment with paclitaxel, trastuzumab, and pertuzumab.

In addition, the investigators are evaluating how the body's immune system works with paclitaxel, trastuzumab, and pertuzumab to kill cancer cells. For this reason, the investigators will collect samples of the participant's breast tumor and samples of the participant's blood over time to understand the reaction of the immune system to the participant's tumor.

Conditions: Breast Cancer
Being tested: Paclitaxel, Trastuzumab, Pertuzumab
Keywords: Breast Cancer
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
Paclitaxel is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug
TrastuzumabDrug
Also called Herceptin
Trastuzumab works by targeting the HER2/neu receptor on cancer cells
PertuzumabDrug
Also called Perjeta
Pertuzumab is a monoclonal antibody which targets the surface of the cells human epidermal growth factor receptor 2 protein (HER2) on the cancer cell, interfering with HER2 causing cancer cell death

Study groups in NCT03716180
Study group	Role	What they receive
Paclitaxel+Trastuzumab+Pertuzumab	Experimental	Paclitaxel is administered intravenously on days 1, 8, and 15 of each 21-day cycle Trastuzumab is administered intravenously on day 1 of each 21-day cycle Pertuzumab is administered intravenously on Day 1 of each 21-day cycle Receives: Drug: Paclitaxel; Drug: Trastuzumab; Drug: Pertuzumab

What is being measured

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

Adjuvant chemotherapy Received
To assess adherence to protocol-specified antibody doublet therapy in the adjuvant setting among patients with stage II-III HER2+ breast cancer who achieve pathologic complete response (pCR) following neoadjuvant Paclitaxel/Trastuzumab/Pertuzumab (THP).
Measured: 2.5 years

Secondary outcomes (9)

pCR rate
To assess pathologic complete response (pCR) for 1) all patients, 2) hormone receptor positive (HR+) patients, and 3) hormone receptor negative (HR-) patients
Measured: 2 years
Residual Cancer Burden (RCB) scores
To assess residual cancer burden (RCB) in 1) all patients, 2) hormone receptor positive patients (HR+), 3) hormone receptor negative (HR-) patients. RCB is scored from 0 to 3, (with possible values 0, 1, 2, 3), where 0 is the best score and indicates eradication of all disease at the time of surgery, and 3 is the worst score, indicating poor response to preoperative therapy.
Measured: 2 years
Reasons for Off-Protocol Escalation per study-specific questionnaires
Patients and physicians will complete questionnaires to assess reasons for off-protocol escalation (meaning, a decision to administer post-operative chemotherapy, for patients with pCR). Standardized questionnaires for both patients and physician reviewers have been developed specifically for this study. Responses are qualitative and do not involve a scale.
Measured: 2 years
Reasons for Off-Protocol De-Escalation per study-specific questionnaires
Patients and physicians will complete questionnaires to assess reasons for off-protocol de-escalation (meaning, a decision not to administer post-operative chemotherapy, for patients without pCR). Standardized questionnaires for both patients and physician reviewers have been developed specifically for this study. Responses are qualitative and do not involve a scale.
Measured: 2 years
One Year of Trastuzumab and Pertuzumab
To assess the percentage of patients completing one year of HP
Measured: 3 years
Event-Free Survival (EFS)
To measure event-free survival (EFS), and to compare EFS in the following subgroups: 1) Patients with pCR versus patients without pCR; 2) Patients with RCB 0 or 1, versus patients with RCB 2 or 3
Measured: 12 years
Recurrence-Free Interval (RFI)
To measure recurrence-free interval (RFI), and to compare RFI in the following subgroups: 1) Patients with pCR versus patients without pCR; 2) Patients with RCB 0 or 1, versus patients with RCB 2 or 3
Measured: 12 years
Overall survival (OS)
To measure overall survival (OS) as an exploratory endpoint
Measured: 12 years
Post-THP (Paclitaxel/Trastuzumab/Pertuzumab) imaging findings and pathology findings in the surgical specimen
To evaluate correlation between post-THP (Paclitaxel/Trastuzumab/Pertuzumab) imaging findings and pathology findings in the surgical specimen
Measured: 2 years

Timeline

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

5 Nov 20181 Sep 2030

First posted23 Oct 2018
Study start5 Nov 2018
Primary completion8 Oct 2020
Study completion1 Sep 2030 (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.
More trials run by Dana-Farber Cancer InstituteThe 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 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03716180
Sponsor's protocol ID: 18-394
Status last verified: Sep 2026
First submitted: 19 Oct 2018
Last updated: 24 Sep 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Tarantino P, Li T, Ogayo ER, Rahman T, DiLullo MK, Patel A, El-Refai S, Abbott C, Li B, Boyle SM, Chen RO, Desai NV, Spring LM, Tung NM, Sinclair N, Faggen M, Constantine M, King TA, Krop IE, Tayob N, Mittendorf EA, Tolaney SM, Winer EP, Parsons HA, Waks AG. Neoadjuvant Paclitaxel, Trastuzumab, and Pertuzumab for Stage II to III, ERBB2-Positive Breast Cancer: A Secondary Analysis of the DAPHNe Trial. JAMA Oncol. 2026 Aug 1;12(8):868-874. doi: 10.1001/jamaoncol.2026.2023.
PubMed 42348190
Weiss A, Li T, Desai NV, Tung NM, Poorvu PD, Partridge AH, Nakhlis F, Dominici L, Sinclair N, Spring LM, Faggen M, Constantine M, Krop IE, DeMeo M, Wrabel E, Alberti J, Chikarmane S, Tayob N, King TA, Tolaney SM, Winer EP, Mittendorf EA, Waks AG. Impact of Neoadjuvant Paclitaxel/Trastuzumab/Pertuzumab on Breast Tumor Downsizing for Patients with HER2+ Breast Cancer: Single-Arm Prospective Clinical Trial. J Am Coll Surg. 2023 Aug 1;237(2):247-256. doi: 10.1097/XCS.0000000000000761. Epub 2023 May 17.
PubMed 37194964
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

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 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: DAPHNe: De-escalation to Adjuvant Antibodies Post-pCR to Neoadjuvant THP (Paclitaxel/Trastuzumab/Pertuzumab)-a Pilot Study in HER2-positive Breast Cancer
ClinicalTrials.gov ID: NCT03716180
Acronym / sponsor ID: 18-394
Conditions: Breast Cancer
Keywords: Breast Cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 100 participants (actual)
Lead sponsor: Dana-Farber Cancer InstituteUniversity, hospital or other
Collaborators: Susan G. Komen Breast Cancer Foundation, Breast Cancer Research Foundation, Terri Brodeur Breast Cancer Foundation
Study start: 5 Nov 2018 (actual)
Primary completion: 8 Oct 2020 (actual)
Study completion: 1 Sep 2030 (estimated)
First posted: 23 Oct 2018 (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 names study drugs involved in this study are:

Paclitaxel (also called Taxol)
Trastuzumab (also called Herceptin)
Pertuzumab (also called Perjeta)

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Paclitaxel+Trastuzumab+Pertuzumab	Experimental	Drug: Paclitaxel, Drug: Trastuzumab, Drug: PertuzumabPaclitaxel is administered intravenously on days 1, 8, and 15 of each 21-day cycle Trastuzumab is administered intravenously on day 1 of each 21-day cycle Pertuzumab is administered intravenously on Day 1 of each 21-day cycle

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (27 listed)

Patients must have Stage II or III (according to AJCC cancer staging manual anatomic staging table, 8th edition) histologically confirmed invasive carcinoma of the breast. A minimum tumor size of 1.5 cm determined by physical exam or imaging (whichever is larger) is required. Patients with inflammatory breast carcinoma (T4d) are NOT eligible.
Tumors must be HER-2 positive, as assessed by standard local institutional protocol (central testing is not required):
Single-probe average HER2 copy number ≥ 6.0 signals/cell; OR
Dual-probe HER2/CEP17 ratio <2.0 with an average HER2 copy number ≥ 6.0 signals/cell; OR
Dual-probe HER2/CEP17 ratio ≥2.0

Key exclusion criteria (7 listed)

Pregnant or nursing women due to the teratogenic potential of the study drugs.
Active, unresolved infection.
Receipt of intravenous antibiotics for infection within 7 days prior to registration.
Uncontrolled hypertension (systolic >180 mm Hg and/or diastolic >100 mm Hg) or clinically significant (i.e. active) cardiovascular disease: cerebrovascular accident/stroke or myocardial infarction within 6 months prior to first study medication, unstable angina, congestive heart failure (CHF) of New York Heart Association (NYHA) Class II or higher (see Appendix B), or serious cardiac arrhythmia requiring medication.
Significant symptoms (Grade ≥ 2) from peripheral neuropathy.

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: TaxolPaclitaxel is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug	Drug	Paclitaxel+Trastuzumab+Pertuzumab
TrastuzumabAlso: HerceptinTrastuzumab works by targeting the HER2/neu receptor on cancer cells	Drug	Paclitaxel+Trastuzumab+Pertuzumab
PertuzumabAlso: PerjetaPertuzumab is a monoclonal antibody which targets the surface of the cells human epidermal growth factor receptor 2 protein (HER2) on the cancer cell, interfering with HER2 causing cancer cell death	Drug	Paclitaxel+Trastuzumab+Pertuzumab

Primary outcome

Adjuvant chemotherapy Received
Time frame: 2.5 years
To assess adherence to protocol-specified antibody doublet therapy in the adjuvant setting among patients with stage II-III HER2+ breast cancer who achieve pathologic complete response (pCR) following neoadjuvant Paclitaxel/Trastuzumab/Pertuzumab (THP).

9 secondary outcomes

pCR rate
Time frame: 2 years
Residual Cancer Burden (RCB) scores
Time frame: 2 years
Reasons for Off-Protocol Escalation per study-specific questionnaires
Time frame: 2 years
Reasons for Off-Protocol De-Escalation per study-specific questionnaires
Time frame: 2 years
One Year of Trastuzumab and Pertuzumab
Time frame: 3 years
Event-Free Survival (EFS)
Time frame: 12 years
Recurrence-Free Interval (RFI)
Time frame: 12 years
Overall survival (OS)
Time frame: 12 years
Post-THP (Paclitaxel/Trastuzumab/Pertuzumab) imaging findings and pathology findings in the surgical specimen
Time frame: 2 years

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 24 Sep 2026.
Derived from this study: PubMed 42348190Tarantino P, Li T, Ogayo ER, Rahman T, DiLullo MK, Patel A, El-Refai S, Abbott C, Li B, Boyle SM, Chen RO, Desai NV, Spring LM, Tung NM, Sinclair N, Faggen M, Constantine M, King TA, Krop IE, Tayob N, Mittendorf EA, Tolaney SM, Winer EP, Parsons HA, Waks AG. Neoadjuvant Paclitaxel, Trastuzumab, and Pertuzumab for Stage II to III, ERBB2-Positive Breast Cancer: A Secondary Analysis of the DAPHNe Trial. JAMA Oncol. 2026 Aug 1;12(8):868-874. doi: 10.1001/jamaoncol.2026.2023.
Derived from this study: PubMed 37194964Weiss A, Li T, Desai NV, Tung NM, Poorvu PD, Partridge AH, Nakhlis F, Dominici L, Sinclair N, Spring LM, Faggen M, Constantine M, Krop IE, DeMeo M, Wrabel E, Alberti J, Chikarmane S, Tayob N, King TA, Tolaney SM, Winer EP, Mittendorf EA, Waks AG. Impact of Neoadjuvant Paclitaxel/Trastuzumab/Pertuzumab on Breast Tumor Downsizing for Patients with HER2+ Breast Cancer: Single-Arm Prospective Clinical Trial. J Am Coll Surg. 2023 Aug 1;237(2):247-256. doi: 10.1097/XCS.0000000000000761. Epub 2023 May 17.
Derived from this study: 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.
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.

Adrienne G Waks, MD principal investigator

Dana-Farber Cancer Institute

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Paclitaxel, Trastuzumab and Pertuzumab in people with Breast Cancer, run by Dana-Farber Cancer Institute at 5 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 27 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: under way, not looking for participants, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Adjuvant chemotherapy Received (time frame: 2.5 years). 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 NCT03716180, 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 24 Sep 2026.