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Prediction of Response to Neoadjuvant Chemotherapy in Women With Operable Breast Cancer (PT-304)

4 octobre 2012 mis à jour par: Precision Therapeutics
The objective of this study is to develop a biomarker to predict pathological complete response in women treated with neoadjuvant chemotherapy for breast cancer. Such a biomarker would assist physicians in selecting the most effective chemotherapy for the individual patient.

Aperçu de l'étude

Statut

Résilié

Les conditions

Intervention / Traitement

Description détaillée

The objective of this study is to develop a biomarker to predict pathological complete response in women treated with neoadjuvant chemotherapy for breast cancer. Such a biomarker would assist physicians in selecting the most effective chemotherapy for the individual patient. The anticipated biomarker will take into account clinical factors (such as tumor stage, tumor size, and age), phenotypic characteristics of the tumor (determined by pathological immunohistochemistry and ex vivo ChemoResponse assay), and genotypic characteristics of the tumor and patient (determined by genomic profiling via gene expression analysis of tumor RNA). It is expected that collective consideration of all of these factors will be more predictive of patient response to therapy than any of them alone.

Approximately 224 evaluable subjects will be recruited from approximately 30 US sites. Women with measurable operable invasive breast cancer diagnosed by core needle biopsy will be eligible for this study. Additional tumor specimens will be obtained prior to the start of chemotherapy via core needle biopsies to be used for the ex vivo ChemoResponse Assay and tumor genomic analysis (gene expression), respectively.

All subjects will receive neoadjuvant chemotherapy with one of two standard of care regimens that must consist of the following agents: doxorubicin (A), cyclophosphamide (C), and a taxane (T) such as docetaxel, paclitaxel, or Abraxane (nanoparticle albumin-bound paclitaxel [nab-paclitaxel]); or, docetaxel (T) and cyclophosphamide (C). These must be administered per NCCN guidelines by the treating physician.

Upon completion of chemotherapy treatment, women will undergo lumpectomy, modified radical mastectomy or other surgical procedure determined appropriate by the investigator and at that time will be evaluated for pathological response. At the time of lumpectomy, modified radical mastectomy, or other surgical procedure, additional tumor excess will be sent to Precision Therapeutics, Inc. (Precision) for exploratory analysis if there is no pathologic complete response (pCR), if there are sufficient tumor cells to send, and if the patient agrees to have her excess tumor cells sent to Precision for this purpose.

During the patient's course of participation on the study, the treating physician will remain blinded to the results of the ChemoResponse Assay and genomic analysis. If it is determined there is no pCR at the time of lumpectomy, modified radical mastectomy or other surgical procedure, Precision will make available a subsequent report to the physician containing additional information about chemotherapy drugs other than ACT that could benefit the further treatment decisions for the patient.

Type d'étude

Observationnel

Inscription (Réel)

134

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • California
      • Long Beach, California, États-Unis, 90806
        • Breastlink Medical Group, Inc
      • Los Angeles, California, États-Unis, 90033
        • USC/Norris Comprehensive Cancer Center
    • Florida
      • Miami, Florida, États-Unis, 33176
        • Advanced Medical Specialties
    • Georgia
      • Marietta, Georgia, États-Unis, 30060
        • Advanced Breast Care
    • Missouri
      • Columbia, Missouri, États-Unis, 65201
        • Missouri Cancer Associates
    • Nevada
      • Henderson, Nevada, États-Unis, 89074
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, États-Unis, 89106
        • Breast Care
    • New Jersey
      • Morristown, New Jersey, États-Unis, 07962
        • Morristown Memorial Hospital
    • New York
      • New York, New York, États-Unis, 10003
        • Beth Israel Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, États-Unis, 73104
        • OU Medical Center
    • Oregon
      • Springfield, Oregon, États-Unis, 97477
        • Willamette Valley Cancer Institute and Research Center
    • Pennsylvania
      • Allentown, Pennsylvania, États-Unis, 18104
        • Breast Care Specialists, P.C.
      • Pittsburgh, Pennsylvania, États-Unis, 15213
        • Magee Womens Hospital
    • Rhode Island
      • Providence, Rhode Island, États-Unis, 02905
        • Women & Infants Hospital
    • Tennessee
      • Germantown, Tennessee, États-Unis, 38138
        • Breast Clinic of Memphis
      • Nashville, Tennessee, États-Unis, 37203
        • Tennessee Breast Specialists
      • Nashville, Tennessee, États-Unis, 37203
        • Advantage Clinical Research
    • Texas
      • Bedford, Texas, États-Unis, 76022
        • Texas Oncology - Bedford
      • Dallas, Texas, États-Unis, 75231
        • Texas Oncology - Dallas Presbyterian Hospital
      • Dallas, Texas, États-Unis, 75246
        • Texas Oncology - Baylor Charles A. Sammons Cancer Center
      • Dallas, Texas, États-Unis, 75230
        • Dallas Surgical Group
      • Dallas, Texas, États-Unis, 75230
        • Leading Edge Research, PA
      • Houston, Texas, États-Unis, 77024
        • Texas Oncology - Memorial City
      • San Antonio, Texas, États-Unis, 78217
        • Cancer Care Centers of South Texas
      • Southlake, Texas, États-Unis, 76092
        • Southlake Oncology
      • Tyler, Texas, États-Unis, 75702
        • Texas Oncology - Tyler
    • Virginia
      • Norfolk, Virginia, États-Unis, 23502
        • Virginia Oncology Associates
    • Wisconsin
      • Milwaukee, Wisconsin, États-Unis, 53233
        • Aurora Sinai Medical Center

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Femelle

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Women 18 years or older with Palpable Operable Breast Cancer Measurable Disease

La description

Inclusion Criteria

Female subjects who satisfy the following conditions will be considered for enrollment into the study:

  1. The subject must consent to be in the research study and must have signed an approved consent form conforming to institutional guidelines prior to study entry.
  2. The diagnosis of breast cancer can be made by FNA or biopsy (other than incisional or excisional). The tumor specimen must demonstrate a diagnosis of invasive adenocarcinoma.
  3. The primary breast cancer must be operable and measurable "greater than or equal to" 2.0 cm by use of physical exam and/or ultrasound, MRI, CT scan, or mammogram.
  4. T1c, T2, T3, or T4 patients clinically staged as M0 (non-inflammatory) are eligible.
  5. Patients with a prior diagnosis and treatment for DCIS are eligible.
  6. Patients with multi-focal breast cancer are eligible.
  7. The tumor must be confined to either the breast or to the breast and ipsilateral axilla.
  8. The subject must be 18 years or older.
  9. The interval between initial cytologic or histologic diagnosis of breast cancer and registration must be no more than 10 weeks.
  10. ECOG Performance Status of 0 or 1 (see Appendix A) is required.
  11. The subject must receive standard of care chemotherapy regimens consisting of either doxorubicin (A), cyclophosphamide (C), and a taxane (T) such as docetaxel, paclitaxel, or nab-paclitaxel administered in any sequence and combination the treating physician determines or docetaxel (T) plus cyclophosphamide (C).

Exclusion Criteria

Male subjects are not eligible for this study as the incidence of breast cancer in male subjects is significantly lower than female subjects. Those subjects who are strongly HER2-positive will be excluded as they will require treatment by biological agents for which the ChemoResponse Assay has not yet been validated. Subjects with evidence of distant metastatic disease are excluded as these subjects would not be good candidates for neoadjuvant therapy. Women who have had an excisional or incisional biopsy prior to entry would not have sufficient tumor sample to test or to be measured by physical exam for the study. Women who have nonmalignant comorbid conditions and diseases that would preclude them from being treated with doxorubicin (A), cyclophosphamide (C), and a taxane (T), and from completing the study are also excluded. Women with psychiatric or addictive disorders are excluded to protect those vulnerable subjects who may not be able to adequately give informed consent.

Women with one or more of the following conditions will be ineligible for this study:

  1. Tumor determined to be strongly HER2-positive by immunohistochemistry (3+) or by fluorescent in situ hybridization (positive for gene amplification)
  2. Definitive clinical or radiologic evidence of distant metastatic disease.
  3. Excisional or incisional biopsy for this primary breast tumor.
  4. Inflammatory breast cancer.
  5. Synchronous contra-lateral breast cancer.
  6. Multi-centric breast cancer.
  7. Participation in the NSABP B-40 study.

  8. Prior therapy for invasive breast cancer, including irradiation, chemo-, immuno-, and/or hormonal therapy.

    a. Note: the only exception is hormonal therapy, which may have been given anytime after diagnosis and before study entry as long as the hormonal therapy is discontinued at or before registration. After surgery, hormonal therapy may be re-started, at the discretion of the treating physician.

  9. Current therapy with any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulator (SERM), either for osteoporosis or breast cancer prevention, or sex hormonal therapy such as birth control pills, ovarian hormonal replacement therapy, etc. These patients are eligible IF these medications are discontinued prior to registration.

  10. Surgical axillary staging procedure prior to study entry.

    a. Note: exceptions include FNA of an axillary node and pre-neoadjuvant sentinel lymph node biopsy for patients with clinically negative axillary nodes.

  11. Nonmalignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude the woman from being treated with doxorubicin (A), cyclophosphamide (C), and a taxane (T), and from completing the study.
  12. Psychiatric or addictive disorders that would preclude obtaining informed consent.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
Primary clinical endpoint pCR will be a dichotomous outcome variable with two levels: complete response and no complete response.
Délai: 24 months
24 months

Mesures de résultats secondaires

Mesure des résultats
Délai
Secondary clinical endpoint cOR will be an ordinal outcome variable with complete response (CR), partial response (PR), stable disease (SD) and progression disease (PD) four levels.
Délai: 24 months
24 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Precision Therapeutics

Collaborateurs

United States Department of Defense

Les enquêteurs

  • Directeur d'études: Darrell Lis, RN, MSN, Precision Therapeutics

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 novembre 2009

Achèvement primaire (Réel)

1 octobre 2012

Achèvement de l'étude (Réel)

1 octobre 2012

Dates d'inscription aux études

Première soumission

3 novembre 2009

Première soumission répondant aux critères de contrôle qualité

3 novembre 2009

Première publication (Estimation)

5 novembre 2009

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

5 octobre 2012

Dernière mise à jour soumise répondant aux critères de contrôle qualité

4 octobre 2012

Dernière vérification

1 octobre 2012

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • PT-304

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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