NCT01042379PHASE2RECRUITING

I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer

I-SPY Trial (Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis 2)

Sponsor: QuantumLeap Healthcare Collaborative

No open prediction endpoints

Endpoints are classified and published by ProgramSignal analysts.

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Key Facts

Study type

INTERVENTIONAL

Conditions

Breast Neoplasms, Breast Cancer, Breast Tumors, Angiosarcoma, TNBC - Triple-Negative Breast Cancer

Interventions

Standard Therapy, AMG 386 with or without Trastuzumab, AMG 479 (Ganitumab) plus Metformin, MK-2206 with or without Trastuzumab

Enrollment

5,000 participants

Primary completion

Dec 2030

Study completion

Dec 2031

First posted

Jan 2010

Last updated

May 2026

Primary Endpoints (CT.gov)

Determine whether adding experimental agents to standard neoadjuvant medications increases the probability of pathologic complete response (pCR) over standard neoadjuvant chemotherapy for each biomarker signature established at trial entry.

Time frame: Post surgery based on upto 36-week treatment

Secondary Endpoints

Establishing predictive and prognostic indices based on qualification and exploratory markers to predict pCR and residual cancer burden (RCB).

To determine three- and five-year relapse-free survival (RFS) and OS among the treatment arms.

To determine incidence of adverse events (AEs), serious adverse events (SAEs), and laboratory abnormalities of each investigational agent tested.

Eligibility Criteria

Inclusion Criteria: * Histologically confirmed invasive cancer of the breast * Clinically or radiologically measureable disease in the breast after diagnostic biopsy, defined as longest diameter greater than or equal to 25 mm (2.5cm) * No prior cytotoxic regimens are allowed for this malignancy. Patients may not have had prior chemotherapy or prior radiation therapy to the ipsilateral breast for this malignancy. Prior bis-phosphonate therapy is allowed * Age ≥18 years * ECOG performance status 0-1 * Willing to undergo core biopsy of the primary breast lesion to assess baseline biomarkers * Non-pregnant and non-lactating * No ferromagnetic prostheses. Patients who have metallic surgical implants that are not compatible with an MRI machine are not eligible. * Ability to understand and willingness to sign a written informed consent (I-SPY TRIAL Screening Consent) * Eligible tumors must meet one of the following criteria: Stage II or III, or T4, any N, M0, including clinical or pathologic…

Read full criteria on CT.gov →

✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov