Cyclophosphamide and Docetaxel Every 3 Weeks as Neoadjuvant Therapy in Locally Advanced Breast Cancer
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.
Tutkimuksen yleiskatsaus
Yksityiskohtainen kuvaus
Opintotyyppi
Vaihe
- Vaihe 2
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Ei käytössä
- Inventiomalli: Yksittäinen ryhmätehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: Single Arm
Cyclophosphamide and docetaxel every 3 weeks as neoadjuvant chemotherapy
|
Cyclophosphamide and docetaxel every 3 weeks as neoadjuvant chemotherapy
Muut nimet:
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Complete Response Rate
Aikaikkuna: 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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change in mean Tiam1 expression levels before and after therapy
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: John S Nystrom, MD, Tufts Medical Center
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
- Ihosairaudet
- Neoplasmat
- Neoplasmat sivustoittain
- Rintojen sairaudet
- Rintojen kasvaimet
- Huumeiden fysiologiset vaikutukset
- Farmakologisen vaikutuksen molekyylimekanismit
- Reumaattiset aineet
- Antineoplastiset aineet
- Immunosuppressiiviset aineet
- Immunologiset tekijät
- Tubuliinimodulaattorit
- Antimitoottiset aineet
- Mitoosin modulaattorit
- Antineoplastiset aineet, alkyloiva
- Alkylointiaineet
- Myeloablatiiviset agonistit
- Doketakseli
- Syklofosfamidi
Muut tutkimustunnusnumerot
- Tufts BR01
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .