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)

Plain English Summary

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 is a Phase 2 clinical trial sponsored by Dana-Farber Cancer Institute studying HER2-positive Breast Cancer, Invasive Carcinoma of the Breast, Breast Cancer, Node Negative Breast Cancer, Micrometastasis Breast Cancer, Hormone Receptor Positive Breast Cancer. This study tests a combination of targeted therapies (pertuzumab and trastuzumab) plus hormone therapy after surgery for early-stage, hormone-receptor-positive, HER2-positive breast cancer. It is for patients who have had surgery for this specific type of breast cancer and have no signs of cancer spread to the lymph nodes or only very small amounts (micrometastases). Participation involves receiving injections of pertuzumab and trastuzumab, and taking oral hormone therapy. Patients will be monitored regularly. Alternatives may include standard adjuvant endocrine therapy alone or in combination with other treatments, depending on individual risk factors and physician recommendations. The trial aims to enroll 393 participants.

Official 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. 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

Who Can Participate

Here is what you need to know about eligibility for this trial. Patients with HER2-positive, hormone-receptor-positive invasive breast cancer that is T1 stage (small tumor size) and has no lymph node involvement or only micrometastases. Patients must have had definitive surgery with clear margins (no cancer left at the edges of the removed tissue) and may have had up to 8 weeks of prior hormone therapy. Individuals must be at least 18 years old, have good general health, and have a normal heart function (Left Ventricular Ejection Fraction >= 50%). Patients with certain prior cancer treatments, active infections, or conditions that would interfere with the study drugs may not be eligible. This trial is studying HER2-positive Breast Cancer, Invasive Carcinoma of the Breast, Breast Cancer, Node Negative Breast Cancer, Micrometastasis Breast Cancer, Hormone Receptor Positive Breast Cancer, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome measures how long patients live without their cancer returning or spreading, assessed at 3 years, meaning it tracks the effectiveness of the treatment in preventing recurrence. The specific primary outcome measures are: Invasive Disease Free Survival at 3 Years (3 Years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.

Why This Trial Matters

This trial aims to improve outcomes for patients with early-stage HER2-positive breast cancer by investigating a novel combination therapy, addressing a need for more effective adjuvant treatments in Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets HER2-positive Breast Cancer, Invasive Carcinoma of the Breast, Breast Cancer, Node Negative Breast Cancer, Micrometastasis Breast Cancer, Hormone Receptor Positive Breast Cancer, where improved treatment options are needed.

Investor Insight

This Phase II study focuses on a specific subtype of breast cancer, indicating a targeted approach to treatment development. Success could lead to a new standard of care, impacting a significant marke Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor about the specific drugs used, how they are given, and the expected duration of treatment. Understand the schedule of visits for injections, blood tests, and check-ups, and how to manage potential side effects. Discuss how this treatment fits into your overall cancer care plan and what to expect after the study concludes. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NA
• Model: SINGLE_GROUP
• Masking: NONE
• Enrollment: 393 participants

Interventions

• COMBINATION_PRODUCT: Pertuzumab+TRASTUZUMAB — Trastuzumab + pertuzumab SC FDC (PHESGO) will be administered on Day 1 of each 21-day cycle , subcutaneous, fixed dose
• DRUG: ADJUVANT ENDOCRINE THERAPY — Oral, daily per cycle

Primary Outcomes

• Invasive Disease Free Survival at 3 Years (3 Years)

Secondary Outcomes

• Invasive Disease Free Survival at 7 Years (7 years)
• Invasive Disease Free Survival at 10 Years (10 years)
• Recurrence-free interval (RFI) at 3 Years (3 Years)
• Recurrence-free interval (RFI) at 7 Years (7 Years)
• Recurrence-free interval (RFI) at 10 Years (10 Years)

Full Eligibility 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 negativ

Trial Locations

• Stamford Hospital, Stamford, Connecticut, United States
• University of Miami- Sylvester Comprehensive Cancer Center, Miami, Florida, United States
• Winship Cancer Institute at Emory University Hospital Midtown, Atlanta, Georgia, United States
• Emory University - Winship Cancer Institute, Atlanta, Georgia, United States
• Winship Cancer Institute at Emory Saint Joseph's Hospital, Atlanta, Georgia, United States
• University of Chicago Medical Center, Chicago, Illinois, United States
• Indiana University Health Schwarz Cancer Center, Indianapolis, Indiana, United States
• Indiana University Health - Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
• Indiana University Sidney and Lois Eskenazi Hospital, Indianapolis, Indiana, United States
• Eastern Maine Medical Center (Northern Light), Brewer, Maine, United States
• ...and 10 more locations

Frequently Asked Questions

Related Conditions

• Breast Cancer
• HER2-positive Breast Cancer
• Hormone Receptor-positive Breast Cancer
• Node-negative Breast Cancer
• Micrometastasis Breast Cancer
• Invasive Ductal Carcinoma
• Early-stage Breast Cancer
• Adjuvant Therapy
• Oncology
• Targeted Therapy

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