araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: A Study to Evaluate the Long-Term Safety of M207 in the Acute Treatment of Migraine

Summary: This is an open-label, twelve-month safety study. There is a screening period followed by a run-in period to record migraine activity. Qualified subjects will receive study medication for up to twelve months for the treatment of multiple migraine attacks. Using the eDiary to confirm they are experiencing a qualified migraine, subjects will self-administer the patches and respond to questions in the eDiary post treatment administration.

Detailed description: This is an open-label, twelve-month safety study. There is a screening period followed by a run-in period (14 to 21 days) to determine eligibility for treatment with study medication based on daily eDiary data collection. Qualified subjects will receive study medication on Day 1 for up to twelve months for the treatment of migraine headaches. Migraines will be treated with a single dose, consisting of two patches, but subjects can treat multiple migraine attacks throughout the 12 months. Using the eDiary to confirm they are experiencing a qualified migraine, subjects will self-administer the patches and continue to respond to questions in the eDiary for 48 hours post treatment administration.

Eligibility: Main Inclusion Criteria:
  1. Women or men 18 to 75 years of age
  2. Greater than 1 year history of episodic, migraine (with or without aura) with onset prior to 50 years of age.
  3. Migraine history during the prior 6 months must include:
  1. at least 2 migraines per month
  2. no more than 8 migraines per month
  3. no more than 15 headache days per month
  4. Women of child-bearing potential must not be pregnant, must agree to avoid pregnancy and use an acceptable double-barrier method of birth control during the trial.
  5. Willing and able to treat a minimum of 2 migraines per month with study medication and consistently complete eDiary for up to 12 months.
  Main Exclusion Criteria:
  1. Contraindication to triptans
  2. Use of SSRIs (drugs like Prozac®) or SNRIs (drugs like Effexor®) or anti-coagulants (drugs like Coumadin®)
  3. Known allergy or sensitivity to zolmitriptan or its derivatives or formulations
  4. Known allergy or sensitivity to adhesives and/or titanium
  5. Women who are pregnant, breast-feeding or plan a pregnancy during this study
  6. Three or more of the following cardiovascular risk factors:
  -  Current tobacco use
  -  Hypertension or receiving anti-hypertensive medication for hypertension
  -  Hyperlipidemia or on prescribed anti-cholesterol treatment
  -  Family history of premature coronary artery disease
  -  Diabetes mellitus
  7. History or current abuse or dependence on alcohol or drugs

Relevance to patient case: not relevant
Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: A Study of SC-005 in Subjects With Triple Negative Breast Cancer (TNBC)

Summary: This is a multicenter, open-label study in participants with triple negative breast cancer (TNBC) to study the safety, tolerability, pharmacokinetics and preliminary efficacy of SC-005. This study consists of 2 parts: Part A (dose regimen finding) followed by Part B (dose expansion).


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed advanced TNBC that is relapsed, refractory, or progressive and not eligible for another standard therapy that would confer clinical benefit to the subject.
  -  Advanced disease is defined as metastatic disease or locally advanced disease that is not amenable to surgery or radiotherapy with curative intent
  -  TNBC is defined as:
  -  <1% staining by immunohistochemistry (IHC) for estrogen (ER) and progesterone (PR) receptors, 0 or 1+ IHC for human epidermal growth factor receptor 2 (HER2), OR
  -  Negative for HER2 amplification by in situ hybridization (ISH) for 2+ IHC disease.
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  -  Adequate hematologic, hepatic, and renal function.
  Exclusion Criteria:
  -  Any significant medical condition including any suggested by Screening laboratory findings that, in the opinion of the Investigator or Sponsor, may place the subject at undue risk from the study.
  -  Has ECG abnormalities that make QT interval corrected (QTc) evaluation difficult (e.g., severe morphologic abnormalities).
  -  Prior exposure to a pyrrolobenzodiazepine or indolino-benzodiazepine based drug, or known hypersensitivity or contraindication to SC-005 or excipient contained in the drug formulation.

Relevance to patient case: not relevant
Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: Circulating Tumor DNA After Neoadjuvant Chemotherapy

Summary: Trial assessing the prognostic value of ctDNA mutations from samples taken sequentially in patients with invasive breast cancer initially treated with neoadjuvant chemotherapy and whose tumor is not in complete histological response.

Detailed description: Patients with an invasive breast cancer on neoadjuvant chemotherapy (with the exception of cT2cN0 tumors) are preselected before the surgical procedure. They are definitely included during the post-surgery visit following the analysis of the surgical specimen (only patients whose tumor did not achieve a complete pathological response are included).
  Sequential plasma samples for ctDNA mutations analysis will be taken during the post-surgery visit (within 2-5 weeks after surgery) and every 6 months (+/- 1 month) thereafter for 5 years.
  In case of relapse patients will be proposed to participate to an optional research program with a blood test for ctDNA assessment and biopsies from a metastasis (when these biopsies are clinically indicated).

Eligibility: Inclusion Criteria :
  1. Age ≥ 18 years (no age limit).
  2. Women or men.
  3. Invasive breast cancer proven histologically at diagnosis (before neoadjuvant chemotherapy):
  1. Locally advanced tumor known to be inoperable from the start:
  -  cT4a, b, c, d whatever the cN
  -  or cN2 or cN3 whatever the cT.
  2. Operable tumors:
  -  cT2cN1 or cT3cN0 or cT3N1,
  -  or cT2cN0 for which ganglionic invasion has been proven by cytology or histology.
  4. Lack of clinically or radiologically detectable metastases in the initial diagnosis before the neoadjuvant chemotherapy (M0).
  5. Unilateral or bilateral breast cancer. Multifocality is accepted.
  6. Patients who received 6 to 8 cycles of neoadjuvant chemotherapy.
  7. Preoperative radiation therapy allowed.
  8. Breast surgery performed and pathology report of a non-complete histological response (i.e. all the different results of ypT0 /is ypN0).
  9. Signed informed consent.
  10. Patients affiliated to a French social security scheme in accordance with Article 1121-11 of the French Code of Public Health.
  11. Possible inclusion in another interventional research (surgical, radiotherapy or drug study).
  Exclusion Criteria :
  1. cT2cN0 tumor without cytological or histological lymph node involvement.
  2. Progression during neoadjuvant chemotherapy.
  3. Exclusive neoadjuvant hormone therapy.
  4. Complete blood transfusion within 120 days prior to 1st sampling.
  5. History of invasive cancer regardless of the time elapsed since the diagnosis of this cancer, including a history of contralateral invasive breast cancer. However, patients who have been treated for in situ breast cancer, basocellular skin cancer or cervical cancer treated in situ are eligible.
  6. Patient unable to follow and comply with research procedures for geographical, social or psychological reasons.
  7. Patient deprived of liberty or subject to a legal protection measure.

Relevance to patient case: not relevant
Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: A Study of TAS0728 in Patients With Solid Tumors With HER2 or HER3 Abnormalities

Summary: This is a First-in-Human (FIH), 2-part, Phase 1/2, open-label, multicenter study design to evaluate the safety, tolerability, PK, pharmacodynamics, PGx, and efficacy of TAS0728. This study consists of Phase 1 and Phase 2 components in subjects with advanced solid tumors with HER2 or HER3 overexpression, amplification, or mutation who have progressed despite standard therapy or for which no standard therapy exists, particularly urothelial cancer, biliary tract cancer, metastatic breast cancer, non-small cell lung cancer and colorectal cancer.


Eligibility: Inclusion Criteria:
  1. Male or females with an age ≥ 18 years.
  2. Subjects with histological- or cytological-confirmed, advanced cancer, who have progressed on (or not been able to tolerate) standard therapy or for whom no standard anticancer therapy exists
  1. For Phase 1, only subjects HER2 or HER3 molecular/genetic alterations will be enrolled.
  2. For Phase 2a, subjects with one of the following tumor types will be enrolled:
  i. Urothelial cancer with HER2 or HER3 mutation ii. Biliary tract cancer with HER2 or HER3 mutation iii. Breast cancer with HER2 or HER3 mutation iv. Breast cancer with HER2 amplification or overexpression v. NSCLC with HER2 or HER3 mutation vi. CRC with HER2 mutation or amplification vii. Other tumors with HER2 mutation/amplification/overexpression or HER3 mutation (gastric/GEJ, endometrial).
  3. At least 1 measurable lesion for solid tumor
  4. Is able to take medications orally (e.g., no feeding tube).
  5. Able to agree to and sign informed consent and to comply with the protocol
  6. Has adequate organ function
  Exclusion Criteria:
  1. Has a serious illness or medical condition(s)
  2. Has received treatment with any proscribed treatments within specified time frames prior to study drug administration
  3. Impaired cardiac function or clinically significant cardiac disease

Relevance to patient case: not relevant
Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: Hypofractionated PBI After BCS for Low-risk Breast Cancer Patients

Summary: The study was designed to evaluate the feasibility and safety of hypofractionated partial breast irradiation after breast-conserving surgery for low-risk breast cancer patients.

Detailed description: A total dose of 40.05Gy in 15 fractions was delivered to the tumor bed for each eligible breast cancer patients. The endpoints including loco-regional recurrence, cosmetic outcomes, and toxicities, were evaluated after treatment.

Eligibility: Inclusion Criteria:
  -  Female
  -  Age≥ 50 years
  -  Treated with breast conversing surgery and sentinel lymph node biopsy or axillary lymph node dissection
  -  Negative surgical margins
  -  Pathologically confirmed invasive breast cancer
  -  A pathological T1N0M0 tumor -IHC: ER+/PR+/HER2-
  -  Tumor bed is labeled with Titanium clips
  -  Received adjuvant hormonal treatment
  -  No adjuvant chemotherapy
  -  ECOG:0-1
  -  Written informed consent.
  Exclusion Criteria:
  -  Age＜50 years
  -  KPS＜70
  -  Treated with neoadjuvant chemotherapy
  -  Treated or being treated with chemotherapy
  -  With severe comorbidity
  -  Previous breast cancer or other malignant tumor history
  -  Previous radiotherapy for breast or thorax
  -  Medical contraindication for radiotherapy
  -  Pregnant or nursing

Relevance to patient case: not relevant
Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: The ONE-MIND Study: Evaluating the Efficacy of Online Mindfulness-Based Cancer Recovery During Chemotherapy Treatment

Summary: Background: Chemotherapy treatment (CT) can have burdensome side effects such as fatigue, nausea-vomiting, and sleep problems that can significantly affect patients' quality of life. Fatigue is the most common, lasting and bothersome of these, which prevents people from working and carrying out daily activities. Mindfulness-Based Cancer Recovery (MBCR) is an evidence-based group training program which has shown to help treat negative physical and psychosocial symptoms in cancer patients. The investigators propose to evaluate a pilot-tested online-MBCR program for patients undergoing CT who may be low on energy, time or have compromised immunity.
  Objectives: To evaluate the impact of participation in online MBCR during CT on fatigue (primary outcome), sleep, pain, nausea/vomiting, mood disturbance, stress symptoms and quality of life (secondary outcomes) as well as cognitive function and return to work (exploratory outcomes) over the course of treatment.
  Methods: The study design is a randomized wait-list controlled trial, conducted during CT for patients with breast or colorectal cancer. Participants will take the 12-week online MBCR program at home within 2 weeks of randomization (immediate group) or after CT completion (waitlist group). Outcomes will be assessed online at, 1) Baseline, 2) Post-MBCR, 3) Post-CT (primary outcome) and 4) 12 months post-baseline.
  Anticipated Findings: MBCR is a promising adjuvant program that could help patients prevent, delay or diminish aversive symptoms and side-effects associated with CT, particularly fatigue. If helpful, online-MBCR could be made easily available at cancer centers worldwide and significantly lessen the burden of cancer treatments.


Eligibility: Inclusion Criteria:
  1. Men and women over the age of 18
  2. Diagnosed with either a) stage I-III HER 2 normal breast carcinoma or b) Stage II-III colorectal carcinoma
  3. Scheduled to undergo either neoadjuvant or adjuvant: a) FEC- D or AC-T chemotherapy or b) FOLFOX or CAPEOX chemotherapy
  4. Weekly access to high-speed internet
  5. Access to a computer/tablet/smart phone
  6. Able to attend MBCR classes at scheduled times
  7. Sufficient ability to speak and read English
  8. Willingness to be randomized into immediate or waitlist groups and complete all assessments
  Exclusion Criteria:
  1. Metastatic patients
  2. Suffering from current Major Depressive Disorder, Bipolar Disorder or other psychiatric disorder (self-report)
  3. Currently engaging in meditation one or more times per week within the previous year.
  4. Participation in an MBCR or MBSR program in the last five years.
  5. Cognitive impairment (>6 on the Brief Screen for Cognitive Impairment)
  6. Physical functional impairment that would interfere with the ability to participate in the intervention (on the PAR-Q questionnaire)

Relevance to patient case: not relevant
Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: IORT Following Breast Conserving Surgery for Early Stage Breast Cancer Registry

Summary: This is a prospective, registry trial which will enroll women aged 65 and above with early stage, low risk breast cancer who will be treated with partial mastectomy and intraoperative radiation therapy (IORT). The primary aim is to determine the 5-year risk of in-breast tumor recurrence. Secondary aims include identification of acute- and late-toxicity, cosmetic result, disease-free survival and overall survival.


Eligibility: Inclusion Criteria:
  -  Female
  -  ECOG performance status 0-1
  -  Age 65 years or older
  -  cT1 or cT2 (≤3.0 cm)
  -  Invasive ductal carcinoma histology
  -  Estrogen receptor positive (ER+)
  -  Grade 1 or Grade 2
  -  Clinically negative lymph nodes (cN0) by examination, imaging and/or nodal sampling
  -  Suitable for breast conserving surgery and radiation therapy
  -  Patient must be able to provide study-specific informed consent
  Exclusion Criteria:
  -  Multi-centric cancer not amenable to single lumpectomy
  -  Prior ipsilateral whole breast radiation
  -  Known BRCA 1 or BRCA 2 mutation
  -  Status post neoadjuvant hormonal or chemotherapy
  -  Invasive lobular histology
  -  Pure ductal carcinoma in situ (DCIS)
  -  Grade 3
  -  Diffuse suspicious microcalcifications

Relevance to patient case: not relevant
Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: Moving on After Breast Cancer Plus- for Breast Cancer Survivors

Summary: Breast cancer (BC) ranks second among all the types of cancer and is equally common in developing as well as developed countries. Breast cancer is most common type of cancer worldwide and its diagnosis as well as early treatment is associated with distress. The aim of this study is to explore the feasibility of integrating a 'Moving on After Breast Cancer (ABC)' manual developed by service user (Dr A Saleem) within a Positive Health Programme (PHP) for Pakistani women who are breast cancer (BC) survivors attending primary care and oncology services in Pakistan B) refine the Moving on ABC plus so as to develop a culturally appropriate therapeutic programme to be tested in a future definitive randomized controlled trial.

Detailed description: According to an estimate of World Health Organization (2000) cancer was responsible for 12% of all the deaths from all causes worldwide and rate of cancer is expected to increase 50% by the year 2020. In Pakistan every ninth women has a chance of developing breast cancer, which is highest rate in Asia. The estimated incidence rate of breast cancer in Pakistan is 50/100,000. Despite the high association of distress with breast cancer, data on prevalence of depression in women with breast cancer especially in low income countries is limited .
  The proposed project consists of two phases: 1) Phase 1: Integration of the two existing interventions Moving On ABC and the Positive Health Programme and the refinement of the integrated intervention. 2) Phase 2: Feasibility Randomized Control Trial (RCT). Sample size of Phase II will be comprised of 50 patients. Patients will be divided into two groups. One group (n = 25) will receive Group moving on ABC Plus intervention and other group (n = 25) will receive routine care.

Eligibility: Inclusion Criteria:
  -  Female
  -  Early breast cancer (stage I and stage II)
  -  Has received primary treatment for breast cancer
  -  Diagnosed as depressed through SCID
  -  Age 18 and above
  Exclusion Criteria:
  -  Women with metastatic breast cancer
  -  Already diagnosed with any psychiatric illness
  -  Already taking psychiatric medicines
  -  Severe cognitive impairment (not able to give consent to take part in intervention)

Relevance to patient case: not relevant
Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: Accelerated Partial Breast Irradiation With IMRT in Early Breast Cancer

Summary: This study is to evaluate the efficacy and toxicity of accelerated partial breast irradiation (ABPI) with intensity modulated radiation therapy (IMRT) in low-risk breast cancer treat with breast-conserving surgery.

Detailed description: This study is a national multicenter phase II prospective clinical trial to enroll low-risk breast cancer treat with breast-conserving surgery. All eligible patients will receive ABPI to a total dose of 40Gy, in 10 fractions, 4Gy/fx/day, within 2 weeks. Intensity modulated radiation therapy (IMRT) technique is used. During Follow up, the locoregional recurrence,survival,acute and late adverse events,and quality of life will be prospectively evaluated.

Eligibility: Inclusion Criteria:
  -  Life Expectation: > 5 years
  -  Enrollment date no more than 12 weeks after breast-conserving surgery or no more than 8 weeks after adjuvant chemotherapy
  -  Histologically confirmed diagnosis of invasive ductal carcinoma (grade 1-2), or mucinous carcinoma, or papillary carcinoma, or tubular carcinoma, or medullary carcinoma: primary tumor ≤ 3.0cm in maximum diameter and pN0; or histologically confirmed DCIS: primary tumor ≤ 2.5cm in maximum diameter, low-medium grade
  -  Unifocal tumour (confirmed by diagnostic MRI)
  -  No lymphovascular invasion
  -  ER positive (defined as medium-strongly nuclear staining in >1% of the cancer cells)
  -  Negative radial resection margins of >= 2 mm
  -  Surgical clips placed in the tumor bed
  -  Written informed consent.
  Exclusion Criteria:
  -  Stage Ⅱ-Ⅲ
  -  Multifocal tumors
  -  Histologically confirmed diagnosis of invasive ductal carcinoma (grade 3), invasive micropapillary carcinoma, carcinoma of lobular in situ, invasive lobular carcinoma
  -  Paget's disease of the nipple
  -  Underwent oncoplastic surgery of ipsilateral breast
  -  Underwent neoadjuvant chemotherapy or hormonal therapy
  -  Previous or simultaneous contralateral breast cancer
  -  Undergone ipsilateral chest wall radiotherapy
  -  Active collagen vascular disease.

Relevance to patient case: not relevant
Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: Evaluation of Mammographic Breast Density in Participants With Hormone Receptor-Negative Breast Cancer Enrolled on Study A011502

Summary: This phase III trial evaluates mammographic breast density in participants with hormone receptor-negative breast cancer enrolled on study A011502. High breast density has been shown to be a strong risk factor for developing breast cancer and decreasing breast density may decrease the risk for breast cancer. Participants treated with aspirin may show reduced breast density on a mammogram.

Detailed description: PRIMARY OBJECTIVES I. To compare the 1-year mammographic breast density in the contralateral (unaffected) breast between the aspirin and placebo arms in patients with hormone receptor negative breast cancer enrolled in A011502.
  SECONDARY OBJECTIVES I. To compare the 2-year mammographic breast density in the contralateral (unaffected) breast between the aspirin and placebo arms in patients with hormone receptor negative breast cancer enrolled in A011502.
  OUTLINE:
  Participants provide bilateral screening mammogram taken prior to all cancer treatment and within 8 weeks prior to registration to A011502 and an annual bilateral mammogram as near as possible to 1 year post-registration to A011502 and as near as possible to 2 years post-registration to A011502. Participants also undergo collection of blood sample and menstrual cycle data within 2 weeks after registration and at 1 and 2 years after registration to A011502.
  After completion of study, participants are followed up annually until 10 years from registration to study A011502.

Eligibility: Inclusion Criteria:
  -  Must be concurrently enrolling to Alliance A011502. Eligible patients may be either pre- or post-menopausal.
  -  Patients must have hormone receptor-negative breast cancer.
  -  Patients must have baseline breast density measurement as defined by one of the following:
  -  >= 25% breast density, or
  -  Scattered areas of fibroglandular density, or
  -  Breast composition category b, c, or d, per Breast Imaging Reporting and Data System (BI-RADS) 2013.
  -  Baseline digital screening mammogram (mediolateral [MLO] and craniocaudal [CC] views) taken within 8 weeks prior to registration must be available for submission.
  * If baseline mammogram within 8 weeks is not available, a new screening mammogram must be performed prior to treatment on Alliance A011502. To receive reimbursement for the cost of this additional mammogram, institutions may submit the A211601 Reimbursement Form, which is available on the Alliance and Cancer Trials Support Unit (CTSU) web pages.
  -  Patients receiving endocrine therapy (e.g., tamoxifen, aromatase inhibitors) are not eligible.
  -  Contralateral unaffected breast in place (with no prior cancer or radiation, no implants and no plan for breast surgery on contralateral breast over the course of the study). Patients with a prior biopsy on the unaffected breast are eligible.
  -  Not pregnant and not nursing.

Relevance to patient case: not relevant