Home › Trials › NCT04569747

Combination treatment for early-stage HER2-positive breast cancer

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)

Phase 2 Interventional Dana-Farber Cancer Institute · NCT04569747

This study is testing a new combination of targeted therapies and hormonal treatment for people with early-stage HER2-positive breast cancer after surgery to see if it helps them recover better.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment375 (estimated)
Ages18 Years and up
SexAll
SponsorDana-Farber Cancer Institute Academic / other
Drugs / interventionspertuzumab, chemotherapy, Radiation, trastuzumab
Locations28 sites (Stamford, Connecticut and 27 other locations)
Trial IDNCT04569747 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of a combination of HER2-directed therapies, trastuzumab and pertuzumab, along with hormonal therapy for patients with hormone receptor-positive, HER2-positive breast cancer following surgery. Participants will receive these treatments for a duration of one year, with hormonal therapy continuing for approximately five years. The study aims to evaluate the safety and efficacy of this investigational drug combination in treating this specific type of breast cancer, involving around 375 participants. Comprehensive screening, laboratory evaluations, and follow-up visits will be conducted throughout the trial.

Who should consider this trial

Good fit: Ideal candidates include individuals with HER2-positive, node-negative or micrometastatic invasive breast cancer.

Not a fit: Patients with HER2-negative breast cancer or those with advanced-stage disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve outcomes for patients with early-stage HER2-positive breast cancer.

How similar studies have performed: Other studies have shown promising results with similar combinations of HER2-directed therapies and hormonal treatments in breast cancer.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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.
* 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.

Exclusion Criteria:

* 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).
* 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

Where this trial is running

Stamford, Connecticut and 27 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions HER2-positive Breast CancerInvasive Carcinoma of the BreastBreast CancerNode Negative Breast CancerMicrometastasis Breast CancerHormone Receptor Positive Breast Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.