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ShortStop-HER2: Comparing 6 vs. 12 Months of HER2-Targeted Therapy for Early Breast Cancer

This study, called ShortStop-HER2, is comparing two different lengths of treatment with HER2-targeted medications, trastuzumab (Herceptin) and pertuzumab, for people with early-stage HER2-positive breast cancer. These medications work by blocking signals that help cancer cells grow. You might be able to join if you have HER2-positive breast cancer, are 18 or older, and had no remaining invasive cancer in your breast or lymph nodes after your initial chemotherapy with trastuzumab. The study wants to see if 6 months of treatment is as effective as 12 months in preventing cancer recurrence, and also to compare quality of life between the two groups. The study is currently unclear on its recruitment status and plans to enroll 1524 participants.

Study design
This interventional study aims to enroll 1524 participants to compare two treatment durations. It is a phase III trial, meaning it compares a new treatment or approach to a standard one.
What's involved
You would receive trastuzumab and pertuzumab, given either intravenously (IV) or subcutaneously (SC). You would also undergo echocardiography (ECHO), multigated acquisition scans (MUGA), and mammography.
Compensation
Not stated in the trial record.
Follow-up
Your recurrence-free survival will be measured for up to 10 years after randomization. Your quality of life will be assessed at 12 months.

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NCT06876714

ShortStop-HER2: 12 Months vs. 6 Months of HER2-targeted Medications for People With HER2+ Breast Cancer Who Had a Pathologic Complete Response After Chemotherapy Plus Trastuzumab

Recruiting
PHASE3Ages 18+InterventionalTreatment
Alliance for Clinical Trials in Oncology
~1,524 participants
Updated 2026-08-05 on ClinicalTrials.gov
What's tested:Trastuzumab (Herceptin)PertuzumabEchocardiographyMultigated Acquisition ScanMammographyUltrasound

At a glance

Recruiting sites
597 of 684 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recurrence-free survival (RFS)
Measured over From randomization to invasive local, regional or distant breast cancer recurrence, or death from any cause prior to a documented disease recurrence, assessed up to 10 years
+1 more outcome measured

Conditions

Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Early Stage HER2+ Breast Cancer

Explore related trials

Breast CarcinomaERBB2 Gene

Where it's being run

684 sites across 49 states
Illinois72
California49
Wisconsin49
Pennsylvania48
Michigan40
Missouri31
Kansas26
North Carolina26

Study leadership

  • Adrienne Waks, MD · STUDY_CHAIR · Alliance for Clinical Trials in Oncology

Who to contact

Jack Beranek
[email protected]
773-702-9171
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patients (females and males) with clinical stage T1c-T3 (or Tx) and nodal stage N0-N1 (except T3N1 tumors, which are not eligible)
Patients must have no residual invasive disease in the breast or lymph nodes after the completion of neoadjuvant therapy. Residual ductal carcinoma in situ (DCIS) is allowed. Patients with residual isolated tumor cells at surgery are considered node-positive and are not eligible
HER2+ by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines. Central pathology review is not required. In cases where there were multiple tumor sites in breast/nodes that had HER2 testing at diagnosis, at least one site must have been HER2+ AND the treating investigator must feel it is in the patient's best interest to be treated as having HER2+ breast cancer
Known hormone receptor status as defined by ASCO/CAP guidelines. Estrogen receptor (ER) and progesterone receptor (PR) of any values are allowed. Hormone receptor positive status can be determined by either known positive ER or known positive PR status; hormone receptor negative status must be determined by both known negative ER and known negative PR
If invasive disease was present in both breasts, participation in the study is permitted as long as the eligibility criteria are met for both tumors/breasts (including the requirement that at least one biopsied site on each side must have been HER2+)
Age ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Patients must have received neoadjuvant chemotherapy in combination with trastuzumab with or without pertuzumab for a minimum of 12 weeks. All chemotherapy must have been completed preoperatively
Patient must complete a minimum of 12 weeks of coverage with trastuzumab and a maximum of 24 weeks in the combined neoadjuvant and adjuvant setting prior to trial registration. Trastuzumab may have been administered either weekly or once every 3 weeks (q3weeks). (For purposes of this eligibility criterion, a single dose of q3week trastuzumab would provide 3 weeks of coverage; a single dose of once a week (q1week) trastuzumab would provide 1 week of coverage. If a q3week dose of trastuzumab were administered and then the subsequent dose was delayed for any period of time, that would still count as 3 weeks of coverage.)
Administration of endocrine therapy for treatment of this breast cancer is allowed prior to trial registration. If a patient received prior breast cancer endocrine therapy (eg tamoxifen or aromatase inhibitor) for DCIS or preventive indication, and endocrine therapy is indicated for treatment of their current breast cancer, then prior endocrine therapy must have been stopped \> 12 months prior to registration on this protocol
No use of investigational anti-cancer agents at time of registration
Patient must register within 14 weeks of final surgery
Adequate excision: Surgical removal of all clinically evident disease in the breast and lymph nodes as follows:
Breast surgery: Total mastectomy with grossly negative margins (in the opinion of the surgeon there is no disease grossly at the margins) or breast-conserving surgery with histologically negative margins (no ink on tumor, including DCIS) unless those margins are anterior at the skin or posterior at the chest wall and no additional margin re-excision can be performed
Lymph node surgery: Lymph node surgery must have been performed and can include sentinel lymph node biopsy, targeted axillary dissection, or axillary dissection, at the discretion of the breast surgeon
Adequate radiation: Patients who completed breast-conserving surgery (i.e. lumpectomy) must have received or plan to receive adjuvant radiation. If breast-conserving surgery was performed but patient will not be receiving breast radiation, the patient is not eligible. Patients for whom radiotherapy would be recommended for breast cancer treatment but for whom it is contraindicated because of medical reasons (e.g., connective tissue disorder or prior ipsilateral breast radiation) are not eligible
Adjuvant radiation can be given on study, and in this case is encouraged to be given concurrently with adjuvant HER2-directed therapy, per investigator discretion
Targeting of the regional nodal basins will be at treating investigator discretion
Not pregnant and not nursing, because this study involves agents with known teratogenic potential. Therefore, for women of childbearing potential only, a negative serum or urine pregnancy test should be performed prior to receiving HER2-directed therapy according to local standard practice
Adequate hepatic, renal and bone marrow function to receive adjuvant HER2-directed therapy in the opinion of the treating investigator. There are no specific required laboratory values for eligibility
No stage IV (metastatic) breast cancer
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
No history of any prior (ipsilateral \[ipsi-\] or contralateral) invasive breast cancer. Prior DCIS is allowed
No evidence of recurrent disease following preoperative therapy and surgery
Patients living with HIV who are healthy and deemed by their medical team to have a low risk of AIDS-related illnesses are included in this trial. Patients with Hepatitis B or Hepatitis C virus who are healthy and deemed by their medical team to meet all other enrollment criteria are included in this trial.
Patients with inadequate cardiac function on most recent assessment of left ventricular ejection fraction (LVEF) are not eligible for this trial. Inadequate cardiac function is defined as LVEF \< 50% on echocardiogram (echo) or multiple-gated acquisition (MUGA)
No history of grade 3 or 4 toxicity related to trastuzumab. If pertuzumab is planned to be given on trial, patient must also have no history of grade 3-4 toxicity related to pertuzumab
No contraindication to receipt of further HER2-directed therapy
No patients with severe, uncontrolled systemic disease that may interfere with planned trial therapy.

What this trial measures

  • Recurrence-free survival (RFS)From randomization to invasive local, regional or distant breast cancer recurrence, or death from any cause prior to a documented disease recurrence, assessed up to 10 years

    The Kaplan-Meier method will be used to estimate the distribution of RFS times and a stratified log-rank test for non-inferiority will be used to assess whether RFS with 6 total months of human epidermal growth factor receptor 2 (HER2)-blockade is non-inferior to standard-of-care 12 total months of HER2-blockade in this patient population. Stratified Cox modeling will be used to estimate the hazard ratio and corresponding one-sided 95% confidence interval (CI).

  • Functional Assessment of Cancer Therapy-Breast (FACT-B) total score (Quality of life)At 12 months

    Will compare the FACT-B total score between patients randomized to receive 6 months versus 12 months of combined neoadjuvant/adjuvant HER2 blockade. All questionnaires will be scored according to published scoring algorithms, including recommendations for addressing missing items within a scale. An intention-to-treat (ITT) approach will be used for all analyses. All statistical tests will be 2-sided, and p-values \< 0.05 will be considered statistically significant. To evaluate the between-arm mean difference in scores, a repeated measures mixed model will be estimated based on FACT-B total scores at all time points.