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Trial record 69 of 99 for:    FEC

Assessing the Response Rate of Neo-adjuvant Taxotere and Trastuzumab in Nigerian Women With Breast Cancer

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ClinicalTrials.gov Identifier: NCT03879577
Recruitment Status : Not yet recruiting
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Brief Summary:
This is a one stage phase II study with a single arm design. It will be conducted in HER-2 positive breast cancer patients in Nigeria who are chemotherapy/hormonal treatment naive.

Condition or disease Intervention/treatment Phase
Breast Cancer Breast Cancer Female HER2-positive Breast Cancer Breast Cancer Stage II Breast Cancer Stage III Drug: Docetaxel Drug: Herceptin Drug: FEC Drug: Tamoxifen Drug: Letrozole Drug: LHRH agonist Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessing REsponse to Neoadjuvant Taxotere and Trastuzumab in Nigerian Women With HER2-positive Breast Cancer (ARETTA)
Estimated Study Start Date : April 10, 2019
Estimated Primary Completion Date : April 10, 2022
Estimated Study Completion Date : April 10, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Docetaxel
Investigators will give patients docetaxel through drip every 3 weeks for four doses for 12 weeks before a repeat breast ultrasound. After breast ultrasound, if the investigator feels the injection is good, surgery will be done.
Drug: Docetaxel
Administered to all patients for a minimum of 4 cycles for 12 weeks.

Herceptin
Herceptin will be given to patients under the skin of the thigh every 3 weeks for 18 times if they are HER2-positive
Drug: Herceptin
Administered for 18 cycles every three weeks (52 weeks) for each patient starting at the first day of treatment with docetaxel.
Other Name: Trastuzumab

Fluorouracil Epirubicin Hydrochloride Cyclophonsphamide (FEC)
Patients with a poor response to docetaxal will receive FEC injection by drip every 3 weeks.
Drug: FEC
Only administered to patients who received docetaxel and herceptin and were assessed as having poor response (defined as stable disease or progressive disease or partial response inoperable).

LHRH (luteinizing hormone-releasing hormone)
All Premenopausal patients will receive LHRH agonist for two years every 3 months for contraception and fertility preservation.
Drug: LHRH agonist
Administered to all premenopausal patients.

Tamoxifen or letrozole
Hormone-receptor positive patients will receive hormonal therapy with tamoxifen or letrozole after surgery, radiotherapy and LHRH agonist according to the expression of hormone receptors and according to the state of primary menopause at the onset of the study.
Drug: Tamoxifen
Only administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole.

Drug: Letrozole
Only administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole.




Primary Outcome Measures :
  1. Measure the complete pathologic response (pCR) [ Time Frame: 4-6 months ]
    Pathological complete response in the breast is defined as the absence of invasive cells at microscopic examination of the primary tumor and lymph nodes at surgery. Any remaining in-situ lesions are permissible. Participants with invalid/missing pCR assessments will be defined as non-responders.


Secondary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: 4-6 months ]
    Incidence and severity of adverse drug reactions (AE) and serious adverse drug reactions (SAE) including clinical laboratory values, vital signs, ECGs and dose interruptions.

  2. Time until progression free survival (PFS) [ Time Frame: From start date of therapy to the date of first documented disease progression or death from any cause, whichever may come first, assessed up to 10 years ]
  3. Duration of response (DOR) [ Time Frame: From first reponse to the date of first documented disease progression or death, assessed up to 10 years ]
  4. Analysis of changes from baseline using the quality of life (QoL) instrument: EORTC [ Time Frame: From start date of therapy to the date of first documented disease progression or death from any cause, whichever may come first, assessed up to 10 years ]
    The various domains of QoL over time and the changes from baseline using the validated (by the European Organization for Research and Treatment of Cancer (EORTC)) QoL instrument (global and breast module).

  5. Blood concentrations of Herceptin SC given in combination with Docetaxel [ Time Frame: 21 days ]
    Blood concentrations of Herceptin SC at multiple time points using the peak exposure

  6. Drug plasma concentration of Herceptin SC given in combination with FEC [ Time Frame: 21 days ]
    Determine the pharmacokinetic profile of Herceptin SC given in combination with FEC following poor response to TH

  7. The cardiac toxicity associated with TscH with FEC +scH in breast cancer patients [ Time Frame: Through study completion an average of two years ]
    The percentage of participants with Heart failure (NYHA Class III or IV or as confirmed by a cardiologist) and a decrease in LVEF of at least 10 EF points from baseline and to below 50%.

  8. The cardiac toxicity associated with TscH without FEC +scH in breast cancer patients [ Time Frame: Through study completion an average of two years ]
    The percentage of participants with Heart failure (NYHA Class III or IV or as confirmed by a cardiologist) and a decrease in LVEF of at least 10 EF points from baseline and to below 50%.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Women ages of 18 to 70 years old
  2. Biopsy-accessible breast tumor of significant size for core needle biopsy/ultrasound measurable (≥ 2cm)
  3. Patients with histologically confirmed carcinoma of the female breast with 3+ positive HER2 status by IHC
  4. Clinical stages IIA -IIIC (AJCC 2009)
  5. Chemotherapy-naïve patients (for this malignancy)
  6. Performance status: ECOG performance status 0−1 (Appendix A)
  7. Non-pregnant and not nursing. Women of childbearing potential must take the pregnancy test and must commit to receive LHRH agonist Zoladex (goserelin) for two years starting from the commencement of the study medications
  8. Required Initial Laboratory Data. Adequate hematologic, renal and hepatic function, as defined by each of the following:

1. Granulocyte ≥ 1,500/μL 2. Platelet count ≥ 100,000/μL 3. Absolute neutrophil count (ANC) ≥ l500/μL 4. Hemoglobin ≥ 10g/dL 5. Bilirubin ≤ 1.5 x upper limit of normal 6. SGOT and SGPT < 2.5 x upper limit of normal 7. Creatinine within institutional normal limits or glomerular filtration rate ≥ 30 mL/min/1.73 m2 by CKD EPI equation (see http://mdrd.com/ for calculator)

9. ECHO: Baseline left ventricular ejection fraction of ≥ 55%

Exclusion Criteria:

  1. Pregnant or lactating women. Women of childbearing potential not using a reliable and appropriate contraceptive method. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential. Patients of childbearing potential will agree to continue the use of acceptable form of contraception for 24 months from the date of last Herceptin administration.
  2. Patients with distant metastasis (brain and/or visceral metastasis)
  3. Serious, uncontrolled, concurrent infection(s).
  4. Treatment for other carcinomas within the last 5 years, except non-melanoma skin cancer and treated cervical carcinoma in-situ (CCIS)
  5. Participation in any investigational drug study within 4 weeks preceding the start of study treatment
  6. Other serious uncontrolled medical conditions that the investigator feels might compromise study participation including but not limited to chronic or active infection, HIV-positive patient, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled Diabetes mellitus, or psychiatric illness/social situations that would limit compliance with study requirements.
  7. Patients with HER2-negative disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03879577


Contacts
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Contact: Ilona Siljander, RN 1-773-702-4298 isiljander@medicine.bsd.uchicago.edu

Locations
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Nigeria
University College Hospital, Ibadan, Nigeria Not yet recruiting
Ibadan, Nigeria
Contact: Chibuzor Afolabi    234-803-727-2413    gafolabi08@gmail.com   
Principal Investigator: Olufunmilayo I Olopade, MD         
Sponsors and Collaborators
University of Chicago
Investigators
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Principal Investigator: Olufunmilayo I Olopade, MD University of Chicago

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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT03879577     History of Changes
Other Study ID Numbers: IRB18-1178
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by University of Chicago:
breast cancer
breast cancer stage II
Breast Cancer Stage III
Docetaxel
Herceptin
neoadjuvant treatment
nigeria

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Trastuzumab
Letrozole
Tamoxifen
Hormones
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Immunological
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Estrogen Antagonists
Hormone Antagonists
Antineoplastic Agents, Hormonal
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents