Clinical Trials Logo
  1. Home
  2. Locally Advanced Breast Cancer
  3. NCT00237133
  4. Details
NCT00237133 Clinical Trial

Treatment of Locally Advanced Breast Cancer With Letrozole in Postmenopausal Women

Locally Advanced Breast Cancer Clinical Trial

— PREDICT  

Official title:
PREDICT TRIAL- Neoadjuvant Treatment of Locally Advanced Breast Cancer With Letrozole in Postmenopausal Women Expressing Hormonal Receptors ( ER and PR)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00237133
Other study ID # CFEM345EBR01
Secondary ID
Status Completed
Phase Phase 4
First received October 9, 2005
Last updated February 22, 2017
Start date March 2003
Est. completion date January 21, 2009

Study information
Verified date February 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Open-label Phase IV trial of Letrozole 2,5mg po/day for 120 days prior to surgery for patients with locally advanced breast in postmenopausal women expressing hormonal receptors ( ER and PR)

Recruitment information / eligibility
Status Completed
Enrollment 112
Est. completion date January 21, 2009
Est. primary completion date January 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Postmenopausal women

2. Primary locally invasive breast cancer

3. Histological confirmed by core needle biopsy, whose tumors are estrogen (ER) and / or progesterone (PgR) positive, defined by core biopsy immunohistochemistry with > 10% positive malignant epithelial cells.

4. Post menopausal status

5. Tumor measurable by clinical examination, mammography and ultrasound

Exclusion Criteria:

1. Prior treatment with letrozole or tamoxifen.

2. Patients with bilateral breast tumors

3. Patients who are eligible for breast conserving surgery

4. Evidence of inflammatory breast cancer or distant metastasis.

5. Other concurrent malignant disease

6. Concomitant anti-cancer treatments such as chemotherapy

Other protocol-defined exclusion criteria may apply.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Letrozole
1 tablet of Letrozole 2.5 mg orally adminnistered once a day

Locations
Country Name City State
Brazil Novartis Investigative Site Barretos - SP
Brazil Novartis Investigative Site Florianopolis - SC
Brazil Novartis Investigative Site Fortaleza/CE
Brazil Novartis Investigative Site Goiania/GO
Brazil Novartis Investigative Site Jau -SP
Brazil Novartis Investigative Site Porto Alegre/RS
Brazil Novartis Investigative Site Ribeirao - SP
Brazil Novartis Investigative Site Rio de Janeiro
Brazil Novartis Investigative Site Santo Andre
Brazil Novartis Investigative Site Sao Paulo/SP
Brazil Novartis Investigative Site Vitoria/ES

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety and tolerability of Letrozole frequency and severity of the clinical adverse events
See also
  Status Clinical Trial Phase
Completed NCT01048918 - Characterization of Circulating Tumor Cells (CTC-s) in Patients With Locally Advanced or Metastatic Stage IV Breast Cancer
Recruiting NCT05383196 - Onvansertib + Paclitaxel In TNBC Phase 1/Phase 2
Recruiting NCT05744375 - Trastuzumab Deruxtecan in First-line HER2-positive Locally Advanced/MBC Patients Resistant to Trastuzumab+Pertuzumab Phase 2
Terminated NCT01837563 - Monitoring of Neoadjuvant Therapy in Locally-Advanced Breast Cancer N/A
Recruiting NCT03978663 - Three Fraction Radiation to Induce Immuno-Oncologic Response N/A
Active, not recruiting NCT04352777 - Impact of Endocrine Therapy and Abemaciclib on Host and Tumor Immune Cell Repertoire/Function in Advanced ER+/HER2- Breast Cancer Phase 2
Recruiting NCT06064812 - A Phase I Clinical Trial of FWD1802 in Patients With ER+/HER2- BC. Phase 1
Recruiting NCT05963997 - A Study of Samuraciclib and Elacestrant in Participants With Metastatic or Locally Advanced HR+/HER2-negative Breast Cancer Phase 1/Phase 2
Recruiting NCT06080620 - The Choice of Treatment Methods and Efficacy of LABC N/A
Completed NCT05002868 - Safety, Pharmacokinetics and Anti-tumor Activity of RP12146, in Patients With Solid Tumors Phase 1
Active, not recruiting NCT02595762 - A Study of Treatment Patterns and Outcomes in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Unresectable Locally Advanced or Metastatic Breast Cancer
Active, not recruiting NCT02965950 - The p53 Breast Cancer Trial Phase 2
Completed NCT01785992 - A Study of the Safety and Effectiveness of Irosustat When Added to an AI in ER+ve Locally Advanced or Metastatic Breast Cancer. Phase 2
Completed NCT00764036 - Study of Artesunate in Metastatic Breast Cancer Phase 1
Active, not recruiting NCT03685331 - HOPE: Olaparib, Palbociclib and Fulvestrant in Patients With BRCA Mutation-associated, HR+, HER2-metastatic Breast Cancer Phase 1
Completed NCT05021900 - Efficacy and Safety of Tenalisib (RP6530), a PI3K δ/γ and SIK3 Inhibitor, in Patients With Locally Advanced or Metastatic Breast Cancer Phase 2
Withdrawn NCT04088032 - Neoadjuvant Study of Abemaciclib, Durvalumab, and an Aromatase Inhibitor Early Stage Breast Cancer Early Phase 1
Completed NCT00455273 - Dynamic Breast MRI in Assessing Locally Advanced Breast Cancer
Terminated NCT04042051 - Copanlisib in Combination With T-DM1 in Pretreated Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer Phase 1
Recruiting NCT05582499 - Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy Phase 1/Phase 2

External Links