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

4. oktober 2012 oppdatert av: 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.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

134

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Primary clinical endpoint pCR will be a dichotomous outcome variable with two levels: complete response and no complete response.
Tidsramme: 24 months
24 months

Sekundære resultatmål

Resultatmål
Tidsramme
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.
Tidsramme: 24 months
24 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Precision Therapeutics

Samarbeidspartnere

United States Department of Defense

Etterforskere

  • Studieleder: Darrell Lis, RN, MSN, Precision Therapeutics

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. november 2009

Primær fullføring (Faktiske)

1. oktober 2012

Studiet fullført (Faktiske)

1. oktober 2012

Datoer for studieregistrering

Først innsendt

3. november 2009

Først innsendt som oppfylte QC-kriteriene

3. november 2009

Først lagt ut (Anslag)

5. november 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

5. oktober 2012

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. oktober 2012

Sist bekreftet

1. oktober 2012

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • PT-304

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