Is NCT07895511 recruiting in Harrison, NY?

Yes, NCT07895511 is currently enrolling participants at its Harrison, NY location. This her2-positive breast cancer clinical trial is accepting qualified participants.

How do I join the her2-positive breast cancer clinical trial in Harrison?

To join this clinical trial in Harrison, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Harrison clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

HER2-positive Breast Cancer Clinical Trial in Harrison, NY

Who Can Participate

Inclusion Criteria

A patient cannot be considered eligible for this study unless ALL of the following conditions are met. Please contact the study PI for exceptions, or if uncertainties arise.

The trial is open to female and male patients who have undergone breast conserving surgery and have received neoadjuvant\

or adjuvant systemic therapy with a HER2-targeted therapeutic regimen.

The maximum window between surgery (neoadjuvant cohort) or last chemotherapy (adjuvant cohort) and enrollment is 90 days.

While the standard duration of neoadjuvant or adjuvant systemic therapy is at least 12 weeks, patients will be eligible if they receive a minimum of 8 weeks of systemic therapy. Patients treated with an antibody-drug conjugate (ADC; eg. T-DM1 or T-DXd) must have received at least 6 cycles of this treatment. \*For the neoadjuvant cohort: Patients are eligible if they achieved pCR with HER2-targeted preoperative treatment. Pathologic complete response is defined as ypT0/TisN0 based on surgical pathology. Patients treated with and ADC must have received at least 6 cycles of this treatment.

The patient must be ≥18 years of age.

The patient must have an ECOG performance status of 0, 1, or 2/Karnofsky performance status above 60.

Histologically or cytologically confirmed invasive breast carcinoma.

The tumor must have been determined to be HER2-positive by current ASCO/CAP guidelines based on local testing results.

The tumor must have ER and PgR status assessed.

The following staging criteria must be met according to AJCC 8th edition criteria: Adjuvant cohort

Following resection, the patient's primary tumor must be ≤ 3 cm.

Surgical axillary evaluation via sentinel node biopsy or axillary dissection

Surgical lumpectomy margins must be negative for invasive cancer and ductal carcinoma in situ (no ink on tumor). Neoadjuvant cohort:

Prior to neoadjuvant therapy, the patient's primary tumor must be \<5 cm by imaging studies with negative axillary nodes (cN0) based on axillary U/S, CT, PET or MRI. Physical examination alone is not sufficient documentation of cN0 status.

The patient must have undergone surgical axillary nodal evaluation demonstrating ypN0 (eg. axillary node dissection, sentinel node biopsy with at least 3 sentinel lymph nodes removed, or sentinel node biopsy followed by axillary node dissection).

Must be ypT0/TisN0 at surgery (lumpectomy); patients with residual non invasive disease (DCIS) in the surgical specimen (ypTis), are only eligible if residual DCIS spans ≤1 cm, and surgical margins are negative for DCIS.

Bilateral mammogram or MRI within 52 weeks prior to enrollment.

Exclusion Criteria

Definitive clinical or radiologic evidence of metastatic disease.

On the Adjuvant cohort, patients with a primary tumor \>3 cm on pathologic examination of the surgical specimen. On the Neoadjuvant cohort, patients with a primary tumor \>5 cm or with abnormal or suspicious ipsilateral axillary nodes by pretreatment imaging, unless demonstrated to be negative by cytologic or histologic examination.

Pathologically positive axillary nodes at any time including of pN0(i+) or pN0(mol+) ypN0(i+) or ypN0(mol+) disease.

Patient planning for or status-post mastectomy.

Radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary lymph nodes, unless there is histological confirmation that these nodes are negative for metastatic disease.

Suspicious microcalcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast), or mass or non-mass enhancement on MRI (if performed) aside from the known cancer, unless biopsied and found to be benign.

Non-epithelial breast malignancies such as sarcoma or lymphoma.

Multicentric carcinoma (invasive cancer or DCIS) in more than one quadrant or multifocal disease spanning \>4 cm. If multifocal, all foci should be confined to a maximum summed tumor extent of 3 cm determined by pathological assessment.

Paget's disease of the nipple.

Synchronous contralateral invasive breast cancer or DCIS or synchronous ipsilateral invasive breast cancer of a different histology. (Patients with synchronous and/or previous contralateral LCIS are eligible).

On the Adjuvant cohort, surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation. (If surgical margins are rendered free of disease by re-excision, the patient is eligible).

Treatment plan that includes regional nodal irradiation.

Patients treated for a prior invasive breast malignancy are excluded. Contralateral DCIS ≥10 years prior to enrollment is permissible.

Patients on oral, transdermal, or subdermal estrogen replacement (including all estrogen only and estrogen-progesterone formulas) are not eligible unless discontinued prior to enrollment.

Use of any investigational product within 30 days prior to enrollment.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Harrison?

Yes, this clinical trial (NCT07895511) has an active research site in Harrison, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

HER2-positive Breast Cancer Treatment Options in Harrison, NY

If you're searching for her2-positive breast cancer treatment options in Harrison, NY, this clinical trial (NCT07895511) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Harrison research site is actively enrolling participants for this clinical trial. You'll receive care from experienced her2-positive breast cancer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all her2-positive breast cancer clinical trials near you to find additional studies recruiting in your area.

HER2-positive Breast Cancer Clinical Trial in Harrison, NY

Expert Care in Harrison

IRB Approved

No-Cost Care

Apply for This Harrison Location

Why Participate?

Simple Process

About This HER2-positive Breast Cancer Study in Harrison