NCT01147016

A Phase II Study of Anti-CD3 x Anti-HER2/Neu (Her2Bi) Armed Activated T Cells (ATC) After Neoadjuvant Chemotherapy in Women With HER2/Neu (0-2+), Hormone Receptor (HR) Negative Stage II-III Breast Cancers

Terminated Phase 2 Results posted Last updated 5 April 2023

What this trial tests

Phase 2 trial testing HER2Bi-armed activated T cells in Breast Cancer in 8 participants. Terminated before completion.

Timeline

1 July 2010

Primary endpoint
1 July 2017

26 July 2017

Quick facts

Lead sponsor	Barbara Ann Karmanos Cancer Institute
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	8
Start date	1 July 2010
Primary completion	1 July 2017
Estimated completion	26 July 2017
Sites	1 location across United States

Drugs / interventions tested

• HER2Bi-armed activated T cells — full drug profile →
• cyclophosphamide (cyclophosphamide) — full drug profile →
• doxorubicin hydrochloride — full drug profile →
• paclitaxel — full drug profile →
• laboratory biomarker analysis
• neoadjuvant therapy
• therapeutic conventional surgery

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Barbara Ann Karmanos Cancer Institute

Who can join

Adults 18 to 120, any sex, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Progression-free Survival
  Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 years..
  Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesion

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Overcoming Challenges for CD3-Bispecific Antibody Therapy in Solid Tumors.
   Middelburg J, Kemper K, Engelberts P, Labrijn AF, et al · · 2021 · cited 122× · PMID 33466732 · DOI 10.3390/cancers13020287
2. Therapies for triple negative breast cancer.
   Andreopoulou E, Schweber SJ, Sparano JA, McDaid HM. · · 2015 · cited 77× · PMID 25881743 · DOI 10.1517/14656566.2015.1032246
3. Bispecific Antibodies as a Development Platform for New Concepts and Treatment Strategies.
   Yang F, Wen W, Qin W. · · 2016 · cited 53× · PMID 28036020 · DOI 10.3390/ijms18010048
4. Recent Discoveries of Macromolecule- and Cell-Based Biomarkers and Therapeutic Implications in Breast Cancer.
   Wu HJ, Chu PY. · · 2021 · cited 32× · PMID 33435254 · DOI 10.3390/ijms22020636
5. T cell coinhibition and immunotherapy in human breast cancer.
   Janakiram M, Abadi YM, Sparano JA, Zang X. · · 2012 · cited 32× · PMID 23114578
6. Current State of Cell Therapies for Breast Cancer.
   Gautam N, Elleson KM, Ramamoorthi G, Czerniecki BJ. · · 2022 · cited 17× · PMID 35880940 · DOI 10.1097/ppo.0000000000000607
7. Neoadjuvant immunotherapy in breast cancer: a paradigm shift?
   Fountzila E, Ignatiadis M. · · 2020 · cited 15× · PMID 33574892 · DOI 10.3332/ecancer.2020.1147
8. Targeting breast cancer stem cells directly to treat refractory breast cancer.
   Pan L, Han J, Lin M. · · 2023 · cited 6× · PMID 37251931 · DOI 10.3389/fonc.2023.981247