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Targeted T Cells After Neoadjuvant Chemotherapy in Treating Women With Stage II or III Breast Cancer Undergoing Surgery

NCT01147016 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2023-04-27

Study results available
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Summary

RATIONALE: Neoadjuvant chemotherapy for women with stage II-III Her negative breast cancer followed by Her2Bi armed activated T cells (ATCs) may significantly improve the pathologic complete response (pCR) rate at the time of surgery. Arming ex vivo expanded T cells in the laboratory may help the T cells kill more tumor cells when they are put back in the body. Giving combination neoadjuvant chemotherapy followed by laboratory-treated T cells before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II clinical trial is studying how well giving laboratory-treated T cells after neoadjuvant chemotherapy works in treating women with stage II or stage III breast cancer undergoing surgery.

Conditions

Interventions

BIOLOGICAL

HER2Bi-armed activated T cells

Total of 4 of the T cell infusions intravenously over a period of 1 month.

DRUG

cyclophosphamide

As prescribed by physician, standard of care.

DRUG

doxorubicin hydrochloride

As prescribed by physician, standard of care.

DRUG

paclitaxel

As prescribed by physician, standard of care.

OTHER

laboratory biomarker analysis

Immune studies will be done pre-immunotherapy, prior to the third infusion of activated T-cells, at the time of surgery, and 1 month after immunotherapy. If there are positive findings, additional optional studies will be done at 3, 6, and 12 months, if the immune studies show changes worthy of follow-up studies.

PROCEDURE

neoadjuvant therapy

As prescribed by physician, standard of care.

PROCEDURE

therapeutic conventional surgery

As recommended by physician, post immunotherapy.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Barbara Ann Karmanos Cancer Institute

    lead OTHER

Principal Investigators

  • Amy Weise, M.D. · Barbara Ann Karmanos Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2017-07-01
Completion
2017-07-26

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01147016 on ClinicalTrials.gov