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Cyclophosphamide and Docetaxel Every 3 Weeks as Neoadjuvant Therapy in Locally Advanced Breast Cancer

8. december 2011 opdateret af: Tufts Medical Center

Cyclophosphamide and Docetaxel Every 3 Weeks as Neoadjuvant Therapy in Locally Advanced Breast Cancer, A Collaborative Trial

The standard therapy for patients who have locally advanced breast cancer is to receive chemotherapy before surgical removal of tumor. This is called neoadjuvant chemotherapy (NAC). Chemotherapy is used to shrink the tumor before surgery, which sometimes may allow for a smaller portion of the breast to be removed. Receiving chemotherapy before surgery may sometimes also allow for smaller portions of the breast to be removed. Getting chemotherapy prior to surgery may also control any hidden metastatic disease and thereby decrease the risk of cancer relapse. Pre-surgery chemotherapy is a standard management approach for locally advanced breast cancer.

Different combinations of drugs can be used as part of the pre-surgery chemotherapy. The purpose of this study is to determine if using a chemotherapy regimen of TC is effective way to manage locally advanced breast cancer (Stage IIA- IIIB) when the TC is given before surgery. The investigators also hope this study will help us to better understand how the tumor tissue is affected by this combination of chemotherapy drugs.

The TC drug combination is FDA approved for use in treating breast cancer, and it has been shown to be equally effective as other commonly used chemotherapy regimens when used after surgery; but, the TC drug combination has not yet been studied in conjunction with NAC for use before surgery. The investigators will be studying the combination of TC used before surgery as a means of possibly shrinking the tumor.

Studieoversigt

Status

Trukket tilbage

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a single-arm, open-label phase II study of cyclophosphamide and docetaxel/taxotere (TC) every 3 weeks in Her2 (-) subjects with locally advanced breast cancer. It is designed to assess (1) the clinical and pathologic response rates to this regimen, as well as its tolerability in this subject population, and (2) the expression of Tiam1 in tumor-associated fibroblasts pre and post treatment.

Undersøgelsestype

Interventionel

Fase

  • Fase 2

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • Women 18 years of age or older
  • Histologically documented adenocarcinoma of the breast, with T2 (T>2.0 cm) N0 or more advanced disease.
  • No evidence of metastatic disease.
  • Disease must be clinically or radio-graphically measurable or evaluable.
  • Incisional or core needle biopsy, yielding sufficient tissue for histologic confirmation of adenocarcinoma, hormone receptor analysis and Her2 testing; and Tiam-1 expression.
  • Subjects may have received no prior chemotherapy for breast cancer. Subjects may have received up to 3 months of neoadjuvant hormonal therapy, provided they have been re-staged and are still eligible for this study, and have been off hormonal therapy at least 48 hours.
  • Subject must be Her-2 negative.
  • Performance status 0-1 by the ECOG scale.
  • Baseline laboratory values must be as follows: Absolute granulocyte count: greater than 1400/cells/ml; Platelets: greater than 100,000 cells/ml; Total bilirubin: less than 1.5 mg/dl; Serum ALT: less than 2.5 x institutional upper normal limit; Creatinine: less than 1.6mg/dl; Hemoglobin: greater than 9.0g/dl
  • Subjects must be nonpregnant and nonlactating. Subjects of childbearing potential must utilize an effective method of contraception during the study.

Exclusion Criteria:

  • Subjects who have received chemotherapy or more than 3 months of neoadjuvant hormone therapy for this cancer.
  • Subjects with metastatic disease (disease beyond the breast, axillary nodes and ipsilateral supraclavicular nodes) or inflammatory breast cancer (T4d).
  • Subjects with other active cancers, except non-melanoma skin cancers
  • Subjects with an active serious infection or other serious underlying medical condition that would otherwise impair their ability to receive protocol treatment.
  • Dementia or significantly altered mental status that would prohibit comprehension of or giving of informed consent.
  • Pregnant or breast-feeding women; sexually active, pre-menopausal women not willing to use adequate methods of birth control.
  • Subjects who are Her 2 neu positive are excluded.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Single Arm
Cyclophosphamide and docetaxel every 3 weeks as neoadjuvant chemotherapy
Medicin: Cyclophosphamide and docetaxel
Cyclophosphamide and docetaxel every 3 weeks as neoadjuvant chemotherapy
Andre navne:
  • Cyclophosphamide: Cytoxan; Docetaxel: Taxotere

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Complete Response Rate
Tidsramme: 3-4 weeks post-surgery
The primary outcome measure for this study is the complete response rate for evaluable participants on neoadjuvant chemotherapy with cyclophosphamide and docetaxel. A clinical complete response (cCR) is defined as resolution of all palpable masses.
3-4 weeks post-surgery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in mean Tiam1 expression levels before and after therapy
Tidsramme: Up to 22 weeks
Descriptive statistic plots and confidence intervals will summarize the observed changes in Tiam1 expression levels before and after therapy. Although primarily descriptive, changes in mean levels pre and post therapy will be tested using the paired t-test or Wilcoxon Signed Ranks Test. Other secondary exploratory analyses will investigate associations between the observed changes in Tiam1 expression and the observed clinical response rate. Regression models will be used to investigate these associations.
Up to 22 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Tufts Medical Center

Efterforskere

  • Ledende efterforsker: John S Nystrom, MD, Tufts Medical Center

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2010

Primær færdiggørelse (Faktiske)

1. december 2011

Studieafslutning (Faktiske)

1. december 2011

Datoer for studieregistrering

Først indsendt

18. oktober 2010

Først indsendt, der opfyldte QC-kriterier

27. oktober 2010

Først opslået (Skøn)

28. oktober 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

12. december 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. december 2011

Sidst verificeret

1. december 2011

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Tufts BR01

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Brystkræft

Kliniske forsøg med Cyclophosphamide and docetaxel

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in South Africa

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner