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HER2-positive Breast CancerPhase 2ADEPTNCT04569747

A Single Arm Phase II Study of ADjuvant Endocrine Therapy, Pertuzumab, and Trastuzumab for Patients With Anatomic Stage I Hormone Receptor-positive, HER2-positive Breast Cancer

A Phase 2 study testing Pertuzumab+TRASTUZUMAB and ADJUVANT ENDOCRINE THERAPY in people with HER2-positive Breast Cancer and Invasive Carcinoma of the Breast, run by Dana-Farber Cancer Institute at 32 sites in United States.

Active, not recruiting

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

Official record
Search all trials

Trial summary

This research study is studying a combination of HER2-directed therapies (trastuzumab and pertuzumab) and hormonal therapy as a treatment after surgery for hormone receptor positive breast cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pertuzumab+TRASTUZUMAB and ADJUVANT ENDOCRINE THERAPY
Could I receive a placebo?
No, everyone receives an active treatment
How many people
393 participants
Where
32 sitesUnited States
Study dates
11 Jan 2021to 1 Sep 2032
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

  • HER2-positive T1 histologically confirmed invasive carcinoma of the breast. Patients must have node-negative (N0) or micrometastases (N1mi) breast cancer according to the AJCC 8th edition anatomic staging table.
  • If the patient has had a negative sentinel node biopsy, then no further axillary dissection is required, and the patient is determined to be node-negative. Axillary nodes with single cells or tumor clusters ≤ 0.2 mm by either H\&E or immunohistochemistry (IHC) will be considered node-negative.
  • Any axillary lymph node with tumor clusters between 0.02 and 0.2cm is considered a micrometastasis. Patients with a micrometastasis are eligible. An axillary dissection is not required to be performed in patients with a micrometastasis found by sentinel node evaluation. In cases where the specific pathologic size of lymph node involvement is subject to interpretation, the Sponsor-Investigator will make the final determination as to eligibility. The investigator must document approval in the patient medical record.
  • Patients who have one or more foci of T1aN0, ER+ (defined as >10%), HER2-negative cancer in the ipsilateral breast, in addition to their primary HER2-positive tumor, are eligible.
  • For unifocal disease, all invasive disease must have been tested for ER and PR (for multifocal disease, see below). Either ER or PR must be positive, defined as ER ≥10% or PR ≥10%. ER- and PR-assays should be performed by immunohistochemical methods according to the local institution standard protocol.
  • HER2-positive by ASCO CAP 2018 guidelines.
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  • Bilateral breast cancers that individually meet eligibility criteria are allowed.
  • Patients with multifocal or multicentric disease are eligible as long as each tumor individually meets eligibility criteria.
  • Patients with a history of ipsilateral DCIS are eligible as long as the patient has not received prior hormonal therapy. Patients with a history of contralateral DCIS are not eligible unless contralateral DCIS was diagnosed at least 15 years ago
  • ≤ 95 days between the date of protocol registration and the patient's most recent breast surgery for this breast cancer
  • Patients must have undergone definitive breast surgery for the current malignancy. All tumor should be removed by either a modified radical mastectomy or a segmental mastectomy (lumpectomy), with either a sentinel node biopsy or axillary dissection
  • -- All margins should be clear of invasive cancer or DCIS (i.e. no tumor on ink). The local pathologist must document negative margins of resection in the pathology report. If all other margins are clear, a positive posterior (deep) margin is permitted, provided the surgeon documents that the excision was performed down to the pectoral fascia and all tumor has been removed. Likewise, if all other margins are clear, a positive anterior (superficial; abutting skin) margin is permitted provided the surgeon documents that all tumor has been removed. Radiation therapy to the conserved breast is required.
  • Patients may have received up to 8 weeks of hormonal therapy as adjuvant treatment for this cancer. Patients should otherwise not have received prior hormonal therapy with the exception that hormonal therapy administered for less than 8-week duration at least 15 years ago is allowed.
  • Prior oophorectomy (including for cancer therapy) is allowed.
  • Patients undergoing breast conservation therapy (i.e. lumpectomy) must not have any contraindications to radiation therapy.
  • Patients who have participated in a window study (treatment with an investigational agent prior to surgery for ≤2 weeks) are eligible. Patients must have discontinued the investigational agent at least 14 days before participation in this study.
  • Men and women with any menopausal status ≥18 years of age
  • ECOG Performance Status 0 or 1
  • Participants must have normal organ and marrow function as defined below:
  • ANC ≥ 1000/mm3
  • hemoglobin ≥8 g/dl
  • platelets ≥ 75,000/mm3
  • AST and ALT both <5x institutional ULN
  • Total bilirubin ≤ 1.5 mg/dL. For patients with Gilbert syndrome, the direct bilirubin should be <institutional ULN
  • Serum creatinine ≤ 2.0 mg/dL OR calculated GFR ≥ 30mL/min
  • Left ventricular ejection fraction (LVEF) ≥ 50%
  • Post-menopausal patients must meet one of the following criteria:
  • Prior bilateral ovariectomy/oophorectomy
  • Age ≥ 60 years
  • Age < 60 years with intact uterus and amenorrhoeic for ≥ 12 consecutive months prior to chemotherapy and/or endocrine therapy exposure (medication-induced amenorrhea is not acceptable to meet this criterion)
  • Age < 60 years hysterectomized and FSH and plasma estradiol levels in the postmenopausal range according to local policies prior to chemotherapy and/or endocrine therapy exposure.
  • Willingness to discontinue contraceptive hormonal therapy, e.g. birth control pills, prior to registration and while on study
  • Premenopausal patients with intact uterus must have a negative serum or urine pregnancy test, including women who have had a tubal ligation and women less than 12 months from their last menstrual period.
  • Women of childbearing potential and men with partners of childbearing potential must be willing to use one highly effective form of nonhormonal contraception or two effective forms of nonhormonal 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 antibody treatment and 3 months after the last dose of hormonal treatment.
  • Patients must be willing and able to sign informed consent.
  • Patients must be willing to provide archival tissue for research purposes.
  • If patient is English-speaking, must be willing to fill out patient questionnaires.

Who cannot join

  • Neoadjuvant or adjuvant chemotherapy for this breast cancer prior to enrollment is prohibited.
  • Any of the following due to teratogenic potential of the study drugs:
  • Pregnant women
  • Nursing women
  • Women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragms, IUDS, surgical sterilization, abstinence, etc). Hormonal birth control methods are not permitted.
  • Men who are unwilling to employ adequate contraception (condoms, surgical sterilization, abstinence, etc).
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  • Participants who are receiving any other investigational agents for treatment of breast cancer, unless specific approval is obtained from the Sponsor-Investigator.
  • Locally advanced tumors at diagnosis, including tumors fixed to the chest wall, peau d'orange, skin ulcerations/nodules, or clinical inflammatory changes (diffuse brawny cutaneous induration with an erysipeloid edge)
  • Patients with a history of previous invasive breast cancer.
  • Individuals with a history of a different malignancy are ineligible except for the following circumstances:
  • Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy.
  • individuals with the following cancer are eligible regardless of when they were diagnosed and treated: cervical cancer in situ, and non-melanoma cancer of the skin.
  • Intercurrent illness including, but not limited to: ongoing or active, unresolved systemic infection, renal failure requiring dialysis, active cardiac disease, prior myocardial infarction (asymptomatic changes on EKG suggestive of old MI is not an exclusion), history of CHF, current use of any therapy specifically for CHF, uncontrolled hypertension, significant psychiatric illness, or other conditions that in the opinion of the investigator limit compliance with study requirements.
  • Time and Motion Substudy Eligibility:
  • Participant must be enrolled at Dana-Farber Cancer Institute
  • Participant must not have discontinued pertuzumab following treatment cycle 1
  • Participant must be able to tolerate subcutaneous administration following cycle 1

Trial locations and contacts

32 sites in 1 country.

32 sites in 1 country

United States32 sites

  • Winship Cancer Institute at Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Emory University - Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Winship Cancer Institute at Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342

  • Dana Farber Cancer Institite

    Boston, Massachusetts, 02115

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Eastern Maine Medical Center (Northern Light)

    Brewer, Maine, 04412

  • New York University Langone Hospital -Brooklyn

    Brooklyn, New York, 11220

  • UNC Rex Hematology Oncology Associated - Cary

    Cary, North Carolina, 27518

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • The Christ Hospital

    Cincinnati, Ohio, 45219

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Dana-Farber Brigham Cancer Center - Foxborough

    Foxborough, Massachusetts, 02035

  • UNC Rex Hematology Oncology Associates of Garner

    Garner, North Carolina, 27529

  • Baylor College of Medicine Medical Center

    Houston, Texas, 77030

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Cape Cod Healthcare Center

    Hyannis, Massachusetts, 02601

  • Indiana University Health Schwarz Cancer Center

    Indianapolis, Indiana, 46032

  • Indiana University Health - Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Indiana University Sidney and Lois Eskenazi Hospital

    Indianapolis, Indiana, 46202

  • Dana-Farber Cancer Insitute at Londonderry Hospital

    Londonderry, New Hampshire, 03053

  • University of Miami- Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

  • Dana-Farber at Milford

    Milford, Massachusetts, 01757

  • New York University Langone Hospital - Long Island

    Mineola, New York, 11501

  • Greco-Hainsworth Centers for Research/Tennessee Oncology

    Nashville, Tennessee, 37203

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37203

  • New York University Langone Health

    New York, New York, 10016

  • UNC Rex Cancer Center

    Raleigh, North Carolina, 27607

  • UNC Rex Cancer Center at Wakefield

    Raleigh, North Carolina, 27614

  • Stamford Hospital

    Stamford, Connecticut, 06904

  • Dana-Farber at South Shore Hospital

    Weymouth, Massachusetts, 02190

Other trials in United States

About this study

Official title: 20-347 NCT Number Title A Single Arm Phase II Study of ADjuvant Endocrine Therapy, Pertuzumab, and Trastuzumab for Patients With Anatomic Stage I Hormone Receptor-positive, HER2-positive Breast Cancer (ADEPT)

This research study is studying a combination of HER2-directed therapies (trastuzumab and pertuzumab) and hormonal therapy as a treatment after surgery for hormone receptor positive breast cancer.

The study drugs involved in this study are:

  • A combination of trastuzumab and pertuzumab given as an injection under the skin (PHESGO)
  • Hormonal (endocrine) Treatment
Read the detailed description

The research study procedures include screening for eligibility and study treatment including laboratory evaluations, physical exams, questionnaires, and follow up visits.

  • Participants will receive HER2-directed treatment for 1 year and hormonal therapy for approximately 5 years.
  • It is expected that about 375 people will take part in this research study.

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug combination to learn whether the drug works in treating a specific disease. "Investigational" means that the drug combination is being studied.

The drugs trastuzumab and pertuzumab are both monoclonal antibodies, which are disease-fighting proteins made by cloned immune cells. The U.S. Food and Drug Administration (FDA) has approved trastuzumab, pertuzumab, and trastuzumab + pertuzumab subcutaneous fixed dose combination (PHESGO) as treatment for HER2 positive breast cancer. The FDA has also approved hormonal therapies as treatment for hormone receptor positive breast cancer.

.

Being tested
Pertuzumab+TRASTUZUMAB, ADJUVANT ENDOCRINE THERAPY
Keywords
HER2-positive Breast Cancer, Invasive Carcinoma of the Breast, Breast Cancer, Node Negative Breast Cancer, Micrometastasis Breast Cancer, Hormone Receptor Positive 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.

  • Pertuzumab+TRASTUZUMABCombination product

    Also called PHESGO

    Trastuzumab + pertuzumab SC FDC (PHESGO) will be administered on Day 1 of each 21-day cycle , subcutaneous, fixed dose

  • ADJUVANT ENDOCRINE THERAPYDrug

    Also called Letrozole, Anastrozole, Exemestane, Tamoxifen

    Oral, daily per cycle

Study groups in NCT04569747
Study groupRoleWhat they receive
PERTUZUMAB + TRASTUZUMAB + ADJUVANT ENDOCRINE THERAPYExperimentalStudy treatment will be administered in 21-day (3- week, +/- 3 days) cycles for one year (18 cycles). * Trastuzumab + Pertuzumab SC fixed dose combination * Hormonal therapy- oral, daily per cycle (may add LHRH agonist per investigator discretion)
Receives: Combination Product: Pertuzumab+TRASTUZUMAB; Drug: ADJUVANT ENDOCRINE THERAPY

What is being measured

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

  1. Invasive Disease Free Survival at 3 Years

    Kaplan-Meier estimates of iDFS will be estimated and plotted with the corresponding 95% confidence intervals.

    from the time of randomization until the occurrence of the first of the following events: invasive local/regional recurrence, Contralateral invasive breast cancer, Distant recurrence, Death from any cause

    Measured: 3 Years

Secondary outcomes (11)

  1. Invasive Disease Free Survival at 7 Years

    Kaplan-Meier estimates of iDFS will be estimated and plotted with the corresponding 95% confidence intervals.

    from the time of randomization until the occurrence of the first of the following events: invasive local/regional recurrence, Contralateral invasive breast cancer, Distant recurrence, Death from any cause

    Measured: 7 years

  2. Invasive Disease Free Survival at 10 Years

    Kaplan-Meier estimates of iDFS will be estimated and plotted with the corresponding 95% confidence intervals.

    from the time of randomization until the occurrence of the first of the following events: invasive local/regional recurrence, Contralateral invasive breast cancer, Distant recurrence, Death from any cause

    Measured: 10 years

  3. Recurrence-free interval (RFI) at 3 Years

    RFI will be estimated and plotted with the corresponding 95% confidence intervals, using Kaplan-Meier estimates for the study as a whole and for subgroups of patients determined by intrinsic subtype (HER2-enriched, luminal, basal Time of randomization until the occurrence of the first of the following events:Invasive local/regional recurrence, Distant recurrence, Death from breast cancer

    Measured: 3 Years

  4. Recurrence-free interval (RFI) at 7 Years

    RFI will be estimated and plotted with the corresponding 95% confidence intervals, using Kaplan-Meier estimates for the study as a whole and for subgroups of patients determined by intrinsic subtype (HER2-enriched, luminal, basal Time of randomization until the occurrence of the first of the following events:Invasive local/regional recurrence, Distant recurrence, Death from breast cancer

    Measured: 7 Years

  5. Recurrence-free interval (RFI) at 10 Years

    RFI will be estimated and plotted with the corresponding 95% confidence intervals, using Kaplan-Meier estimates for the study as a whole and for subgroups of patients determined by intrinsic subtype (HER2-enriched, luminal, basal Time of randomization until the occurrence of the first of the following events:Invasive local/regional recurrence, Distant recurrence, Death from breast cancer

    Measured: 10 Years

  6. Breast cancer-specific survival (BCSS) at 3 Years

    defined as the time period between randomization and death due to breast cancer.

    Measured: 3 Years

  7. Breast cancer-specific survival (BCSS) at 7 Years

    defined as the time period between randomization and death due to breast cancer.

    Measured: 7 Years

  8. Breast cancer-specific survival (BCSS) at 10 Years

    defined as the time period between randomization and death due to breast cancer.

    Measured: 10 Years

  9. Overall survival

    OS will be estimated and plotted with the corresponding 95% confidence intervals, using Kaplan-Meier estimates for the study as a whole and for subgroups of patients determined by intrinsic subtype (HER2-enriched, luminal, basal).

    Measured: randomization and death. Surviving patients classified as lost-to-follow-up or having withdrawn consent to be followed will be censored at their date of last contact or withdrawal of consent to be followed, whichever occurs first up to 10 years

  10. Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v5.0

    NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting

    Measured: baseline to 5 Years

  11. Total patient chair time of drug administration

    Mean difference will be estimated between HP FDC SC and IV admin of HP in sub-study

    Measured: baseline to 18 Months

Timeline

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

  1. First posted30 Sep 2020
  2. Study start11 Jan 2021
  3. Primary completion23 Mar 2029 (estimated)
  4. Study completion1 Sep 2032 (estimated)

Resources

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
393 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04569747
Sponsor's protocol ID
20-347
Acronym
ADEPT
Status last verified
Oct 2026
First submitted
25 Sep 2020
Last updated
6 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Publications

  • Waks AG, Chen EL, Graham N, Frey AM, Almeida K, Attaya V, Ryding C, Abbass I, Fung A, Sussell J, Cortazar P, Harvey C, Leth D, Faggen M, Sinclair N, Walsh J, Tung N, Sinclair S, Lo S, Yardley D, Valero V, Meisel J, Ballinger TJ, Adams S, Carey LA, Rauch JK, Abramson VG, Williams NO, Chen WY, Leone JP, Schumer ST, Tayob N, Tolaney SM. Subcutaneous vs Intravenous Trastuzumab/Pertuzumab: A Time and Motion Substudy of a Phase II Trial of Adjuvant Trastuzumab/Pertuzumab for Stage I HER2+ Breast Cancer (ADEPT trial). JCO Oncol Pract. 2025 Mar;21(3):351-357. doi: 10.1200/OP.24.00021. Epub 2024 Jul 19.

    PubMed 39028923

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pertuzumab+TRASTUZUMAB and ADJUVANT ENDOCRINE THERAPY in people with HER2-positive Breast Cancer and Invasive Carcinoma of the Breast, run by Dana-Farber Cancer Institute at 32 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 37 inclusion and 17 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 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 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?

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?

Invasive Disease Free Survival at 3 Years (time frame: 3 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 NCT04569747, which also lists 1 linked publication.

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 Oct 2026.

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