araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 56-year-old female with breast cancer; genetic feature: ERBB2

Clinical trial: Study Evaluating Neratinib Versus Lapatinib Plus Capecitabine For ErbB2 Positive Advanced Breast Cancer

Summary: This is a study of an experimental drug (neratinib) versus a combination of drugs (lapatinib and capecitabine) in women who have erbB-2 (HER-2) positive metastatic or locally advanced breast cancer. The goal of this study is to compare the two regimens in shrinking tumors and extending the lives of women with erbB2 (HER2) positive breast cancer. The study will also compare the safety of the two regimens and to compare quality of life of patients taking the two regimens.


Eligibility: Inclusion Criteria:
  -  Stage IIIB, IIIC, or IV erbB2 (HER2) positive breast cancer
  -  Prior use of Herceptin (trastuzumab), and a taxane
  -  Adequate cardiac and renal function
  Exclusion Criteria:
  -  More than 2 prior Herceptin (trastuzumab) regimens or prior use of Xeloda (capecitabine) and / or Tykerb (lapatinib) [Tyverb]
  -  Bone as the only site of disease
  -  Active central nervous system metastases (subjects should be stable and off anticonvulsants and steroids)
  -  Significant gastrointestinal disorder with diarrhea as major symptom

Relevance to patient case: definitely relevant
Patient case: 56-year-old female with breast cancer; genetic feature: ERBB2

Clinical trial: A Trial l of Panobinostat Given in Combination With Trastuzumab and Paclitaxel in Adult Female Patients With HER2 Positive Metastatic Breast Cancer

Summary: The primary purpose of this study is to identify the maximum tolerated dose (MTD) of both intravenous and oral panobinostat when given in combination with trastuzumab and paclitaxel. The study will evaluate safety and efficacy of the combination in adult female patients with HER2+ metastatic breast cancer


Eligibility: Inclusion Criteria:
  -  Age > 18 year old
  -  Confirmed HER2+ metastatic breast cancer
  -  Prior treatment and progression on trastuzumab
  -  Patients must have adequate organ functions
  -  Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
  Exclusion Criteria:
  -  Patients who have had surgery within last 2 weeks prior to starting the treatment
  -  Patients who receive concurrent therapy for brain metastases
  -  Impaired heart function or clinically significant heart disease
  -  Ongoing diarrhea
  -  Liver or renal disease with impaired hepatic or renal functions
  -  Concomitant use of any anti-cancer therapy or certain drugs
  -  Female patients who are pregnant or breast feeding
  -  Patients not willing to use an effective method of birth control Other protocol-defined inclusion/exclusion criteria may apply

Relevance to patient case: definitely relevant
Patient case: 56-year-old female with breast cancer; genetic feature: ERBB2

Clinical trial: Study Evaluating Bosutinib-Exemestane Combination Vs Exemestane Alone in Post Menopausal Women With Breast Cancer

Summary: This is a phase 2, open-label, multicenter, 2-arm study of bosutinib administered in combination with exemestane versus exemestane alone. This is a 2-part study consisting of a safety lead-in phase and randomized phase 2 portion. Subjects in part 1 will receive bosutinib and exemestane daily, and will be closely monitored for 28 days. If no safety concerns arise, then future eligible subjects will be randomly assigned to the main phase of the study. They will either receive bosutinib daily combined with daily exemestane, or daily exemestane alone for a specified period of time. Subjects will be followed up for survival after treatment discontinuation.

Detailed description: This study was terminated on 19 Apr 2010 due to unfavorable risk benefit ratio which did not support continuation in part 2 of the study. Even if the safety profile of the combination of Bosutinib and Exemestane was acceptable 25% of subjects had treatment related liver events including 14% of severe liver events.

Eligibility: Inclusion Criteria:
  -  Woman aged 18 years or older.
  -  Confirmed pathologic diagnosis of breast cancer.
  -  Locally advanced, metastatic, or locoregional recurrent breast cancer not amenable to curative treatment with surgery or radiotherapy.
  -  Surgically sterile or postmenopausal woman.
  -  Documented ER+ and/or PgR+ and erbB2- tumor.
  -  Progression of locally advanced or metastatic disease during treatment with a nonsteroidal AI or tamoxifen, or progression during treatment with (or within 6 months of discontinuation of) an adjuvant nonsteroidal AI.
  Exclusion Criteria:
  -  Prior exemestane, prior bosutinib, or any other prior anti-Src therapy.
  -  More than 1 prior endocrine treatment for locally advanced or MBC.
  -  More than 1 prior cytotoxic chemotherapy regimen in metastatic setting.
  -  Bone or skin as the only site of disease.

Relevance to patient case: definitely relevant
Patient case: 56-year-old female with breast cancer; genetic feature: ERBB2

Clinical trial: Gene Therapy in Treating Women With Metastatic Breast Cancer

Summary: RATIONALE: Placing the gene for interleukin-12 into breast cancer cells may help the body build an immune response to kill tumor cells.
  PURPOSE: This phase I trial is studying the side effects and best dose of gene therapy in treating women with metastatic breast cancer.

Detailed description: OBJECTIVES:
  -  Determine the toxicity and maximum tolerated dose of intratumoral injection of adenovirus-mediated human interleukin-12 gene in women with metastatic breast cancer.
  -  Determine the tumor response in patients treated with this regimen.
  -  Determine the immune response in patients treated with this regimen.
  OUTLINE: Patients receive a single dose of adenovirus-mediated human interleukin-12 intratumorally via percutaneous needle placement under ultrasound guidance.
  Blood and tumor tissue samples are collected periodically for immunological laboratory studies. Samples are analyzed for serum cytokine levels by ELISA; qualitative analysis of immune biomarkers by IHC staining; and immune cell biomarker analysis by FACS.
  After completion of study therapy, patients are followed periodically.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically or cytologically confirmed metastatic adenocarcinoma of the breast
  -  Malignant disease in the skin, chest wall, or other sites (lymph nodes or primary tumor in the breast) accessible to percutaneous needle placement and injection
  -  Solitary or multiple tumors
  -  Measurable disease in ≥ 2 dimensions by physical examination or CT/MRI scan
  -  Malignant tumors in the skin and chest wall must be ≥ 4 mm in diameter by physical examination
  -  Malignant tumors in other accessible sites must be ≥ 1 cm in diameter on physical examination
  -  Malignant disease in other organs (in addition to skin or chest wall metastases) allowed
  -  Hormone receptor status not specified
  PATIENT CHARACTERISTICS:
  -  Menopausal status not specified
  -  Karnofsky performance status 70-100%
  -  Life expectancy ≥ 16 weeks
  -  Granulocyte count ≥ 1,500/mm^3
  -  Platelet count ≥ 100,000/mm^3
  -  Hemoglobin ≥ 9.0 mg/dL
  -  PT normal
  -  Serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 45 mL/min
  -  Serum total bilirubin ≤ 2.0 times upper limit of normal (ULN)
  -  Serum transaminases ≤ 2.5 times ULN
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Weight ≥ 30 kg (for patients treated with the highest dose level of study drug)
  -  No active infection or concurrent serious medical illness
  -  No HIV positivity
  -  No other malignancy within the past 5 years except for the following:
  -  Inactive nonmelanoma skin cancer
  -  In situ carcinoma of the cervix
  -  Grade 1 papillary bladder cancer
  PRIOR CONCURRENT THERAPY:
  -  More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
  -  No anticoagulant therapy with heparin or warfarin for ≥ 2 months after completion of study treatment

Relevance to patient case: not relevant
Patient case: 56-year-old female with breast cancer; genetic feature: ERBB2

Clinical trial: Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer

Summary: The purpose of this study is to investigate whether neratinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer after adjuvant treatment with trastuzumab.


Eligibility: Inclusion Criteria:
  -  Stage II through IIIC HER-2/erbB-2 positive breast cancer with node positive disease.
  -  Been treated for early breast cancer with standard of care duration of trastuzumab.
  -  Could have been treated neoadjuvantly but have not reached pCR.
  Exclusion Criteria:
  -  Positive clinical and radiologic assessments for local or regional recurrence of disease at the time of study entry.
  -  History of heart disease.
  -  QTc interval >0.45 seconds
  -  History of gastrointestinal disease with diarrhea as the major symptom.

Relevance to patient case: definitely relevant
Patient case: 56-year-old female with breast cancer; genetic feature: ERBB2

Clinical trial: Study Evaluating Bosutinib-Letrozole Combination Versus Letrozole Alone In Post Menopausal Women With Breast Cancer

Summary: This is a phase 2 study of bosutinib administered in combination with letrozole versus letrozole alone in post-menopausal women with breast cancer. This is a 2-part study. Subjects in part 1 will receive bosutinib and letrozole daily, and will be closely monitored for 28 days. The second part will proceed with subjects receiving a dose that is determined to be safe based on the safety evaluation of the first part. Eligible subjects will be randomly assigned to receive either bosutinib daily combined with daily letrozole, or daily letrozole alone for a specified period of time. Subjects will be followed up for survival after study drug discontinuation.

Detailed description: This study was terminated on 19 April 2009 due to unfavorable risk benefit ratio of Bosutinib in combination with Letrozole including one confirmed Hy's law case. 37.5% of patients had treatment related liver events with the majority of severe events resulting in permanent study treatment discontinuation.

Eligibility: Inclusion Criteria:
  -  Surgically sterile or post-menopausal women.
  -  Confirmed pathologic diagnosis of breast cancer.
  -  Locally advanced or metastatic, or loco-regional recurrent breast cancer not amenable to curative treatment with surgery or radiotherapy.
  -  Documented ER+ and/or PgR+ and erbB2- tumor based on most recently analyzed biopsy, as documented by a local laboratory.
  -  At least 1 radiologically measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST).
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  Exclusion Criteria:
  -  Prior letrozole (except in adjuvant setting), prior bosutinib, or any other prior Src inhibitor.
  -  Prior endocrine treatment for locally advanced or metastatic breast cancer (up to one prior adjuvant Aromatase Inhibitor (AI) agent/regimen is permitted).
  -  More than 1 prior chemotherapy regimen in locally advanced or metastatic breast cancer.
  -  Adjuvant endocrine therapy <=12 months prior to day 1 of treatment.
  -  Disease refractory (ie, Progressive disease (PD) within 6 months from initiation of therapy) to previous adjuvant antiestrogen therapy.
  -  Bone or skin as the only site of disease.
  -  Extensive visceral disease or active Central Nervous System (CNS) disease.
  -  Any other cancer within 5 years of screening with the exception of ER+ contralateral breast carcinoma, adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin.
  -  Major surgery or radiotherapy within 14 days of treatment day.
  -  Inadequate hepatic/renal/bone marrow function.
  -  History of clinically significant or uncontrolled cardiac disease.
  -  Serious concurrent illness.

Relevance to patient case: definitely relevant
Patient case: 56-year-old female with breast cancer; genetic feature: ERBB2

Clinical trial: Developing Mouse Models of Breast Cancer Using Tissue Samples From Women With Breast Cancer

Summary: RATIONALE: Changing the genes in laboratory mice to create a living model of human breast cancer may help doctors learn more about breast cancer.
  PURPOSE: This research study is developing mouse models of breast cancer using tissue samples that were previously collected from women with breast cancer.

Detailed description: OBJECTIVES:
  -  To develop new in vivo models of human breast cancer.
  -  To correlate response in this model to actual treatment outcome in patients, if the in vivo model is proven feasible.
  OUTLINE: Previously collected breast tumor fragments are implanted into the renal capsule site of SCID mouse hosts (mouse with severe combined immune deficiency) to establish metastatic spread patterns, and both histologic and molecular tumor characteristics.
  Patients' medical charts are reviewed to obtain relevant information, including general demographics, smoking and alcohol use, as well as outcome data such as survival and response to treatment.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of breast cancer
  -  Any stage of disease
  -  Primary or metastatic disease
  -  Human breast tumor tissues available after the diagnoses have been made
  -  Enrolled on the ongoing Breast Tissue Repository trial VU-VICC-BRE-03103
  -  Have consented to the use of their tissues for research purpose
  -  Hormone receptor status not specified
  PATIENT CHARACTERISTICS:
  -  Menopausal status not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 56-year-old female with breast cancer; genetic feature: ERBB2

Clinical trial: Lapatinib Resistance in Patients With Breast Cancer

Summary: RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about cancer and the development of drug resistance in patients.
  PURPOSE: This research study is looking at lapatinib resistance in patients with breast cancer.

Detailed description: OBJECTIVES:
  -  To identify secondary ErbB2 mutations in tumor tissue samples from patients with ErbB2-positive breast cancer treated with lapatinib ditosylate.
  -  To investigate ErbB2 copy number changes and expression levels.
  -  To determine abnormalities of other pathways (e.g., c-MET and PI3K) as potential mechanisms of resistance.
  OUTLINE: Previously collected tumor tissue samples* are obtained for genetic analysis studies. Samples are analyzed for secondary ErbB2 mutations by nested PCR; ErbB2 copy number changes by quantitative PCR and standard histological FISH; and ErbB2 expression levels by quantitative RT-PCR and IHC. Patients also undergo blood sample collection for extraction of DNA (as normal control DNA) and isolation of EpCAM-positive circulating tumor cells using immunomagnetic cell separation technology. Additional research studies may include mutational and amplification analysis of the c-MET and PI3K pathways.
  NOTE: *Patients may undergo biopsy if a post-treatment tumor tissue sample is unavailable.

Eligibility: DISEASE CHARACTERISTICS:
  -  Pathologically confirmed invasive breast cancer
  -  ErbB2-positive disease
  -  Has received or is currently receiving lapatinib ditosylate
  -  Documented clinical benefit while receiving lapatinib ditosylate (e.g., stable disease of ≥ 12 weeks duration OR a radiographic response)
  -  Must have tumor tissue samples available for research studies
  -  Hormone receptor status not specified
  PATIENT CHARACTERISTICS:
  -  Menopausal status not specified
  -  Not pregnant*
  -  Coagulation profile normal*
  -  Platelet count > 100,000/mm³* NOTE: *For patients requiring a post-treatment biopsy
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics
  -  Concurrent chemotherapy or trastuzumab (Herceptin®) allowed
  -  No concurrent anticoagulants, including warfarin or low-molecular weight heparin*
  -  No concurrent antiplatelet therapy, including aspirin, clopidogrel, or other antiplatelet agents* NOTE: *For patients requiring a post-treatment biopsy

Relevance to patient case: definitely relevant
Patient case: 56-year-old female with breast cancer; genetic feature: ERBB2

Clinical trial: Biomarkers in Native American Women With Breast Cancer

Summary: RATIONALE: Studying samples of tumor tissue in the laboratory from Native American women with breast cancer may help doctors identify and learn more about biomarkers related to breast cancer in these patients. It may also help doctors learn more about the prognosis of these patients.
  PURPOSE: This laboratory study is looking at biomarkers in Native American women with breast cancer.

Detailed description: OBJECTIVES:
  -  Evaluate a selected panel of molecular markers in tissue specimens from Native American women with breast cancer.
  -  Determine which molecular markers provide independent prognostic information with respect to traditional prognostic factors in these patients.
  -  Compare and contrast the prevalence of positivity in Native American women with breast cancer with an age- and stage-matched cohort of Caucasian women with breast cancer enrolled on clinical trial NCCTG-77-30-51 or the Mayo Breast Cancer Registry.
  OUTLINE: Immunohistochemistry is performed on tumor samples to analyze the following molecular markers: estrogen receptor, progesterone receptor, c-erbB2, p53, Ki-67, Bcl-2, Bax, cyclin D-1, and insulin-like growth factor-1R.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of primary adenocarcinoma of the breast in Native American women
  -  Prior surgical treatment for breast cancer within the Aberdeen or Phoenix areas of the Indian Health Service or the Alaska area of the Native Health Service between 1990-2000
  -  Paraffin-embedded tissue available
  -  Paraffin-embedded tissue available from Caucasian women with breast cancer enrolled on NCCTG-77-30-51 or the Mayo Breast Cancer Registry
  PATIENT CHARACTERISTICS:
  Age
  -  18 and over
  Sex
  -  Female

Relevance to patient case: definitely relevant
Patient case: 56-year-old female with breast cancer; genetic feature: ERBB2

Clinical trial: Tamoxifen Resistance in Women With Stage I, Stage II, Stage IIIA, or Stage IIIB Breast Cancer

Summary: RATIONALE: Studying samples of blood from patients with breast cancer in the laboratory may help doctors identify and learn more about biomarkers related to tamoxifen resistance.
  PURPOSE: This laboratory study is looking at tamoxifen resistance in women with stage I, stage II, stage IIIA, or stage IIIB breast cancer.

Detailed description: OBJECTIVES:
  -  Identify women who are resistant to tamoxifen citrate and other drugs for the treatment of breast cancer by testing their plasma for the presence of proteins (e.g., macrophage migration inhibition factor) encoded by resistance-inducing genes (RIGs).
  -  Provide retrospective data on the predictive value of RIGs to serve as the basis for a prospective clinical trial of these genes as predictors of drug resistance.
  OUTLINE: This is a multicenter study. Patients are stratified according to response during tamoxifen citrate (TAM) therapy (resistant group [i.e., those who develop recurrent breast cancer while being treated with TAM] vs conditionally sensitive group [i.e., those who have disease-free survival for over 3 years after initial diagnosis while being treated with TAM]).
  Patients undergo blood collection at baseline, within 3 weeks of initiation of TAM therapy, and then every 6 months for 3 years or until relapse, whichever comes first. Samples are analyzed by enzyme-linked immunosorbent assay for expression of protein biomarkers (i.e., kallikrein gene 10, macrophage migration inhibition factor, prolyl carboxypeptidase, queuine tRNA-ribosyltransferase, and kinesin) encoded by resistance-inducing genes. An additional blood sample is obtained from patients at the time of relapse, if available.
  Patients also undergo assessment of medical history, personal habits, and characteristics of breast cancer (e.g., tumor histology, stage, and grade) at baseline.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed invasive breast cancer
  -  Initial pathologic stage I-IIIB disease
  -  No stage IV disease
  -  Meets the following criteria for breast cancer therapy:
  -  Received prior primary local therapy for breast cancer
  -  Scheduled to begin tamoxifen citrate as adjuvant therapy for breast cancer within 3 weeks
  -  Hormone receptor status:
  -  Estrogen-receptor positive tumor
  -  Female
  -  Pre- or post-menopausal
  -  Must be able to donate 20 mL of blood
  Exclusion Criteria:
  -  Severe anemia, defined as hemoglobin < 11 g/dL
  -  Psychiatric history that would preclude obtaining informed consent

Relevance to patient case: not relevant
Patient case: 56-year-old female with breast cancer; genetic feature: ERBB2

Clinical trial: Phase I/II AZD8931/Paclitaxel in Treatment of Advanced Solid Tumours (Phase I) and Advanced Breast Cancer (Phase II)

Summary: The main purpose of this study is to determine if AZD8931 can improve the efficacy of standard chemotherapy for the treatment of advanced breast cancer. This study will be conducted in 2 parts: the first part (phase I) will determine a dose of AZD8931 that can be safely administered with paclitaxel chemotherapy. The second part (phase II) will determine the efficacy and safety of AZD8931 in combination with paclitaxel chemotherapy in breast cancer.


Eligibility: Inclusion Criteria:
  -  Male/ female with solid, malignant tumour which is unresponsive to standard therapies (Phase I). Female patients with advanced breast cancer with low HER2 expression (Phase II)
  -  Suitable for paclitaxel chemotherapy
  -  Life expectancy more than 12 weeks
  Exclusion Criteria:
  -  Inadequate kidney, liver, heart, gastric, lung or eye function
  -  Hypersensitive to paclitaxel
  -  No symptomatic uncontrolled brain metastases
  -  Previous taxane chemotherapy within 12 months (Phase II)

Relevance to patient case: not relevant
Patient case: 56-year-old female with breast cancer; genetic feature: ERBB2

Clinical trial: Study Evaluating Neratinib Plus Paclitaxel VS Trastuzumab Plus Paclitaxel In ErbB-2 Positive Advanced Breast Cancer

Summary: This study is investigating the effects of an experimental drug (neratinib) in combination with paclitaxel versus trastuzumab in combination with paclitaxel for the treatment of women who have not received previous treatment for erbB-2-positive locally recurrent or metastatic breast cancer. The study will compare the effectiveness of each regimen in shrinking tumors and extending the lives of women with erbB-2 (HER2) positive breast cancer. The study will also compare the safety of the two regimens and as well as the quality of life of subjects receiving either regimen.


Eligibility: Inclusion Criteria:
  -  ErbB-2 positive locally recurrent or metastatic breast cancer
  -  Eastern Cooperative Oncology Group (ECOG) 0-2
  -  Measurable disease
  -  Availability of tumor tissue for HER2 status confirmation
  Exclusion Criteria:
  -  Prior systemic anti-cancer therapy other than endocrine therapy for locally recurrent or metastatic disease
  -  Prior erbB-2 inhibitor other than trastuzumab or lapatinib in the neoadjuvant or adjuvant setting
  -  Progression/recurrence within 12 months after completion of adjuvant or neoadjuvant therapy
  -  history of heart disease
  -  history of gastrointestinal disease

Relevance to patient case: definitely relevant