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Trial record 35 of 100 for:    FEC

Phase II Neoadjuvant in Inflammatory Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00756470
Recruitment Status : Terminated (Slow accrual.)
First Posted : September 22, 2008
Results First Posted : November 5, 2014
Last Update Posted : November 17, 2014
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical research study is to learn how well lapatinib taken alone, followed by taking lapatinib with paclitaxel, and then taking lapatinib with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC75) works to help to control Inflammatory Breast Cancer (IBC). The safety of this drug combination will also be studied.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Lapatinib Drug: Paclitaxel Drug: 5-Fluorouracil (5-FU) Drug: Epirubicin Drug: Cyclophosphamide Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Neoadjuvant Lapatinib Plus Chemotherapy (Sequential FEC75 and Paclitaxel) in Women With Inflammatory Breast Cancer Whose Tumors Overexpress ErbB2 (Her2/Neu)
Study Start Date : October 2008
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Arm Intervention/treatment
Experimental: Neoadjuvant Lapatinib plus Chemotherapy

Four cycles of Lapatinib and Paclitaxel followed by 4 cycles of Lapatinib plus 5-Fluorouracil, Cyclophosphamide, Epirubicin (FEC75). Cycle is 21 days.

Lapatinib alone at 1,000 mg orally once daily for a 2-week run-in period, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each.

  1. Week 3 Paclitaxel 80 mg/m^2 weekly for 4 cycles (12 weeks) administered on Day 1, Day 8, and Day 15) of each cycle combined with Lapatinib 750 mg orally once daily.
  2. Week 15, second combination treatment consisting of Lapatinib (1,000 mg orally once daily) combined with FEC75 (5-FU 500 mg/m^2, Epirubicin 75 mg/m^2, and Cyclophosphamide 500 mg/m^2 every 3 weeks for 4 cycles).
Drug: Lapatinib
1000 mg taken by every day by mouth (PO) weeks 1 and 2; then starting day 15 for 12 weeks (weeks 3 to 14) daily 750 mg PO. Week 15, second combination treatment consisting of lapatinib (1,000 mg orally once daily) combined with FEC7.
Other Names:
  • Tykerb
  • GW572016

Drug: Paclitaxel
80 mg/m^2 intravenously over 1 hour weekly for 4 cycles administered on Day 1, Day 8, and Day 15 of each cycle then weekly starting day 15 for 12 weeks.
Other Name: Taxol

Drug: 5-Fluorouracil (5-FU)
500 mg/m^2 intravenously over 3-5 minutes every three weeks of Weeks 13-24.
Other Names:
  • 5-FU
  • Adrucil
  • Efudex

Drug: Epirubicin
75 mg/m^2 intravenously over 5-10 minutes every three weeks of Weeks 13-24.

Drug: Cyclophosphamide
500 mg/m^2 intravenously over 45-60 minutes every three weeks of Weeks 13-24.
Other Names:
  • Cytoxan
  • Neosar

Primary Outcome Measures :
  1. Rate of Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy [ Time Frame: Assessed at time of surgery following completion neoadjuvant chemotherapy (approximately 26 weeks) ]
    Pathologic complete response (pCR) rate defined as number of participants out of total that had no residual invasive disease (malignant cells) in the breast or axillary lymph nodes as assessed at the time of surgery following completion of all protocol specified neoadjuvant chemotherapy, which is approximately 26 weeks following the start of neoadjuvant chemotherapy.

Secondary Outcome Measures :
  1. Number of Participants With pCR After Completion of All Protocol Specified Therapy & Surgery (Surgical Population) [ Time Frame: Following definitive surgery at completion of neoadjuvant chemotherapy (following approximately 26 treatment weeks) ]
    Pathologic complete response [pCR or RCB Class 0] defined as no residual invasive disease (malignant cells) in the breast or axillary lymph nodes as assessed at the time of surgery following completion of all protocol specified neoadjuvant chemotherapy, which is approximately 26 weeks following the start of neoadjuvant chemotherapy and surgery. the residual cancer burden (RCB) was estimated from routine pathologic sections of the primary breast tumor site and the regional lymph nodes. The calculated RCB index value is categorized as one of four RCB classes, RCB-0 to RCB-III where RCB-0 is best prognosis (no residual disease) to RCB-III a worst prognosis. The RCB score for participants was assessed following completion of all protocol specified therapy, 4 cycles of lapatinib and paclitaxel followed by 4 cycles of lapatinib plus FEC75 and surgery.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Have signed informed consent form (ICF) and a Patient Authorization Form (HIPAA).
  2. Histological confirmation of breast carcinoma with a clinical diagnosis of IBC based on the presence of inflammatory changes in the involved breast, including diffuse erythema and edema (peau d'orange), with or without an underlying palpable mass, involving the majority of the skin of the breast. Pathologic evidence of dermal lymphatic invasion should be noted but is not required for diagnosis.
  3. Tumors that overexpress ErbB2, defined as one of the following definitions: 3+ staining by immunohistochemistry and/or a FISH ratio of more than 2.2
  4. Have either measurable or clinically evaluable skin disease. Patients with metastasis but are candidates for mastectomy are eligible.
  5. Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 - 1.
  6. Have left ventricular ejection fraction (LVEF) within the institutional range of normal as measured by either echocardiogram (ECHO) or MUGA scans. The same modality must be used consistently throughout the study.
  7. Willing to under go 1 mandatory core biopsy (up to 4 passes) and 1 mandatory skin biopsy to confirm IBC diagnosis and for biologic expression profiling.Subjects with clinically palpable residual disease may undergo an optional 2nd and 3rd core needle biopsy (1 after initial 2-week Lapatinib therapy and 1 after 6 months of completing all chemotherapy, before surgery) to allow identification of presumed pathways of therapy resistance. Information may give subject options for other targeted therapies (e.g. trastuzumab) if definitive surgery confirms residual disease.
  8. Are able to swallow and retain oral medication (intact pill).
  9. Are able to complete all screening assessments as outlined in the protocol.
  10. Have adequate organ function.
  11. Are subjects aged >/= 18 years with any menopausal status: Non-child-bearing potential (i.e., women with functioning ovaries who have a current documented tubal ligation or hysterectomy, or women who are postmenopausal) Child-bearing potential (i.e., women with functioning ovaries and no documented impairment of oviductal or uterine function that would cause sterility.) This category includes women with oligomenorrhea (severe), women who are perimenopausal, and young women who have begun to menstruate. Criterion continued in #13
  12. These subjects must have a negative serum pregnancy test at screening and agree to one of the following: Complete abstinence from intercourse from 2 weeks prior to administration of the first dose of study medication until 28 days after the final dose of study medication; or Consistent and correct use of one of the following acceptable methods of birth control: male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject; Criterion continued in # 13
  13. Any intrauterine device (IUD) with a documented failure rate of less than 1% per year; oral contraceptives (either combined or progestogen only) where not contraindicated for this subject population or per local practice.; or barrier methods, including diaphragm or condom with a spermicide. Please note that breast cancer subjects on this trial cannot receive injectable levonorgestrel or injectable progestogen due to the potential for an adverse effect of anti-hormonal therapies on chemotherapy administered for breast cancer.

Exclusion Criteria:

  1. Have received any prior to chemotherapy.
  2. Had prior therapy with an ErbB1 and/or ErbB2 inhibitor.
  3. Are receiving concurrent anti-cancer therapy (chemotherapy, immunotherapy, and biologic therapy) while taking study medication.
  4. Have Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Women with ulcerative colitis are also excluded.
  5. Have a concurrent disease or condition that would make the woman inappropriate for study participation, or any serious medical disorder that would interfere with the woman's safety.
  6. Have an active or uncontrolled infection.
  7. Have dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
  8. Have active cardiac disease, defined as one or more of the following: history of uncontrolled of symptomatic angina, history of arrhythmias requiring medications, or clinically significant; myocardial infarction < 6 months from study entry; uncontrolled or symptomatic congestive heart failure; ejection fraction below the institutional normal limit; any other cardiac condition, which is in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient
  9. Are pregnant or breastfeeding.
  10. Have received concurrent treatment with an investigational agent clinical trial.
  11. Use of any prohibited medications concurrently with lapatinib therapy.
  12. Have used investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study medication.
  13. Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to any of the agents used in this study or their excipients.
  14. Are receiving therapeutic anti-coagulation therapy (i.e. warfarin, heparin)

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 identifier (NCT number): NCT00756470

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United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
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Principal Investigator: Ricardo Alvarez, MD M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00756470     History of Changes
Other Study ID Numbers: 2007-0818
First Posted: September 22, 2008    Key Record Dates
Results First Posted: November 5, 2014
Last Update Posted: November 17, 2014
Last Verified: November 2014

Keywords provided by M.D. Anderson Cancer Center:
Breast Cancer
Inflammatory Breast Cancer
ErbB2 overexpression
Neoadjuvant Chemotherapy

Additional relevant MeSH terms:
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Breast Neoplasms
Inflammatory Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic
Protein Kinase Inhibitors
Enzyme Inhibitors
Antibiotics, Antineoplastic