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Association details:
| Biomarker: | HER-2 negative |
|---|---|
| Cancer: | HER2 Negative Breast Cancer |
| Drug: | capecitabine (Thymidylate synthase inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Excerpt:
Invasive Breast Cancer: HER-2 negative...Preferred regimens…Anti-metabolites…Capecitabine…
Source:
Title:
Adjuvant Capecitabine for Breast Cancer after Preoperative Chemotherapy
Excerpt:
The final analysis showed that disease-free survival was longer in the capecitabine group than in the control group (74.1% vs. 67.6% of the patients were alive and free from recurrence or second cancer at 5 years; hazard ratio for recurrence, second cancer, or death, 0.70; 95% confidence interval [CI], 0.53 to 0.92; P=0.01)...After standard neoadjuvant chemotherapy containing anthracycline, taxane, or both, the addition of adjuvant capecitabine therapy was safe and effective in prolonging disease-free survival and overall survival among patients with HER2-negative breast cancer who had residual invasive disease on pathological testing.
DOI:
10.1056/NEJMoa1612645
Source:
Title:
Metronomic Chemotherapy of Capecitabine After Standard Adjuvant Chemotherapy in Operable Triple Negative Breast Cancer
Excerpt:
...- Definite reports on ER/PR(progesterone receptor)/Her2 receptor showing all ER/PR/Her2 negative (specific definitions: immunohistochemical detection of ER 4 × 10^9/l, neutrophil count> 2 × 10^9/l, platelet count> 100 × 10^9/l and hemoglobin 9g/dl);...
Trial ID:
Source:
Title:
RO4929097 and Capecitabine in Treating Patients With Refractory Solid Tumors
Excerpt:
...- Patient must be HER2/neu negative; HER2 negative will be defined as HER2 neither over-expressed or amplified; HER2 will be considered NOT over-expressed if the tumor stains as 0 or 1+ for HER2 by immunohistochemistry (IHC); if the IHC for HER2 is 2+, fluorescence in-site hybridization (FISH) ratio must be less than 2 to be considered NOT amplified; any tumor for which only FISH was performed must have a ratio of less than 2 to be considered NOT amplified...
Trial ID:
More C2 evidence
Source:
Title:
Maintenance Treatment With Capecitabine Versus Observation in Breast Cancer Patients
Excerpt:
...Tumours must be HER2 negative....
Trial ID:
Source:
Title:
Oral Vinorelbine and Capecitabine in Advanced HER2-negative Breast Cancer
Excerpt:
...- histologically proved metastatic HER-2 negative breast cancer....
Trial ID:
Source:
Title:
Capecitabine Plus Radiotherapy for Local Relapse Breast Cancer With Negative Her2 Tumours
Excerpt:
...- Patients with tumour HER2 negative....
Trial ID:
Source:
Title:
Capecitabine or Endocrinotherapy as a Maintenance Therapy Regimen at Least 2nd Line in Hormone Receptor Positive and HER2 Negative Metastatic Breast Cancer
Excerpt:
......
Trial ID:
Source:
Title:
A Phase 2 Study of Ruxolitinib With Capecitabine in Subjects With Advanced HER2-Negative Breast Cancer
Excerpt:
...2.Histologically or cytologically confirmed HER2-negative adenocarcinoma of the breast, including ER+, PR+, and TNBC. ...
Trial ID:
Source:
Title:
- -
Excerpt:
...1) Woman ≥ 18 years old;2) Histologically confirmed locally advanced (unresectable) or metastatic breast cancer;3) Triple-negative breast cancer:Estrogen receptor (ER)-negative and Progesterone receptor (PgR)-negative, as defined by a < 10 % tumor stained cells by immunohistochemistry (IHC); HER2 negative status (i.e. IHC score 0 or 1+, or IHC score 2+ and FISH/SISH/CISH negative), confirmed centrally before inclusion with FFPE tissue from the primary tumour;4) Androgen receptor (AR)-positive, as defined centrally by a ≥ 10% tumor stained cells by IHCNote: AR assessment by local pathologist before inclusion is not mandatory;5) Patients with a relapse should be chemotherapy naïve or have received a maximum of one line of chemotherapy for advanced disease (providing they are not presenting with life-threatening metastasis); patients could have received adjuvant or neo-adjuvant therapy;6) In the exceptional situation of pre-menopausal patient, the addition of a LHRH analog is recommended (androgens might act as an estrogen antagonist in premenopausal patients);7) Presence of measurable or evaluable disease according to RECIST v1.1;8) ECOG ≤ 1;9) Normal hematological function: ANC ≥ 1.500/mm3; platelets count ≥ 100.000/mm3; hemoglobin > 10 g/dL;Note: subject must not have received any growth factor within 4 weeks or blood transfusion within 7 days of the hematology laboratory sample obtained at screening)10) Normal hepatic function: total bilirubin ≤ 1.5 upper normal limit (UNL) unless this increase is due to a known Gilbert's disease; ASAT and ALAT ≤ 5 UNL (in case of hepatic metastasis);11) Creatinine clearance (MDRD formula) ≥ 50 mL/min;12) Systolic blood pressure (BP) < 160 mm Hg and diastolic BP < 95 mm Hg, as documented on day of registration/consent (Hypertension allowed provided it is currently controlled);13) Cardiac ejection fraction ≥50% measured by MUGA or ECHO done within 4 weeks before inclusion;14) For premenopausal patients, patient agreeing to use effective contraception during and for ≥ 6 months after completion of study treatment;15) Patient able to comply with the protocol;16) Patient must have signed a written informed consent form prior to any study specific procedures;17) Patient must be affiliated to a Social Health Insurance. ...
Trial ID:
Source:
Title:
Paclitaxel Poliglumex and Capecitabine in Treating Patients With Metastatic Breast Cancer
Excerpt:
......
Trial ID:
Source:
Title:
A Multicenter, Randomized Clinical Trail Evaluate Effectiveness and Security of Capecitabine or Endocrinotherapy as a Maintenance Therapy Regimen After the 1st-line Chemotherapy With Capecitabine Combine Regimen in Hormone Receptor Positive and HER2 Negative Metastatic Breast Cancer(Overstep)
Excerpt:
......
Trial ID:
Source:
Title:
Reinduction with liposomal anthracyclines and Capecitabine in patients with breast cancer, locally advanced (IIIA-IIIB-IIIC) HER2 negative, not obtaining a pathological complete response (
Excerpt:
......
Trial ID:
Source:
Title:
Capecitabine and Pseudomonas Aeruginosa Combination in Metastatic Breast Cancer (MBC)
Excerpt:
...Patients with Her-2 negative breast cancer(HER-2 negative or one plus by IHC test , if HER-2 two plus by IHC,FISH result should be negative) 4....
Trial ID:
Source:
Title:
Phase II Single Arm Trial of Low Dose Capecitabine in Patients With Advanced Breast Cancer
Excerpt:
...Histologically or cytologically confirmed breast cancer with HER2 negative status....
Trial ID:
Source:
Title:
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Excerpt:
...- ER/PR-positive (> 1% cells) by IHC and HER2 negative (by IHC or FISH) -...
Trial ID:
Source:
Title:
Adjuvant Metronomic Capecitabine Plus Endocrine Therapy for HR+/HER2- Primary Breast Cancer
Excerpt:
...(1) ER and/or PR positive (positive staining accounted for more than 1% of all tumor cells) (2) HER-2 negative (IHC 0, 1+, or IHC 2 + and...
Trial ID:
Source:
Title:
Metronomic Capecitabine Plus Aromatase Inhibitor for First Line Treatment in HR(+), Her2(-) Metastatic Breast Cancer
Excerpt:
...- Confirmed diagnosis of ER positive/Her2-negative breast cancer...
Trial ID:
Source:
Title:
Study of the Impact of DPD Activity on the Efficacy of Capecitabine
Excerpt:
...- Patients with metastatic HER2 negative breast cancer,...
Trial ID:
Source:
Title:
Efficacy of Supplement Adjuvant Capecitabine in HR+/HER2- Breast Cancer Patients With High Risks
Excerpt:
...- Completed radical breast cancer surgery with confirmed pathology suggested primary invasive breast adenocarcinoma, ER and/or PR positive (defined as positive cells >1%) and HER2 negative (defined as HER2 immunohistochemistry 2+ or less and FISH negative)....
Trial ID:
Source:
Title:
UTD1 Combined With Capecitabine in Metastatic HER2-negative Breast Cancer Patients With Brain Metastases
Excerpt:
...- With histologically confirmed HER2 negative recurrent and metastatic breast cancer...
Trial ID:
Source:
Title:
Pazopanib in Combination With Capecitabine in Patients With Metastatic Breast Cancer
Excerpt:
...- Diagnosis of advanced or metastatic HER2-negative breast cancer....
Trial ID:
Source:
Title:
Phase III Study of Vinflunine Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer
Excerpt:
...Histologically or cytologically confirmed Her-2 negative carcinoma of the breast 3....
Trial ID:
Source:
Title:
Open Label Dose-Finding Study of TRC105 Plus Capecitabine for Metastatic Breast Cancer
Excerpt:
...- Histologically proven metastatic Her-2-negative breast cancer (Part 2 only)...
Trial ID:
Source:
Title:
A Study of Ruxolitinib in Combination With Capecitabine in Subjects With Advanced or Metastatic HER2-negative Breast Cancer
Excerpt:
...- Histologically or cytologically confirmed HER2-negative adenocarcinoma of the breast...
Trial ID:
Source:
Title:
Tesetaxel Every 3 Weeks vs Weekly vs Capecitabine as 1st-line Therapy for Locally Advanced or Metastatic Breast Cancer
Excerpt:
...HER2 negative disease 5....
Trial ID:
Source:
Title:
Utidelone plus capecitabine for inoperable local advanced HER2 negative breast cancer with no response to neoadjuvant anthracycline and taxane treatment: a multi-center, single-arm exploratory study
Excerpt:
...HER2 negative breast cancer confirmed by the pathology at the research center; 5. ...
Trial ID:
Source:
Title:
Study of the impact of DPD activity on the efficacy of capecitabine Etude de l'impact de l'activité DPD sur l'efficacité de la capécitabine
Excerpt:
...Age over 18, PS 0 to 2, Patients with metastatic HER2 negative breast cancer, Patient eligible to a treatment with capecitabine in monotherapy at 2000 mg/m2/D, 14 days every 21 days, Patient with a Uracilemia dosage performed following the French health recommendation Patients with at least one assessable lesion according to the RECIST criteria 1.1. ...
Trial ID:
Source:
Title:
Phase 3 Study of Adagloxad Simolenin (OBI-822)/OBI-821 Treatment for Breast Cancer Patients
Excerpt:
...Histologically documented TNBC (estrogen receptor-negative [ER-] / progesterone receptor-negative [PR-] / human epidermal growth factor 2-negatove [HER2-]) defined as ER-negative and PR-negative (≤5% positive cells stain by IHC for both ER and PR), and negative HER2/neu- status, confirmed on tumor sample.- HER2/neu-negative will be defined as one of the following criteria:- IHC 0 or 1+- Single-probe average HER2 gene copy number of nce of disease after completing standard treatment and meeting ONE of the following criteria:- Neoadjuvant chemotherapy followed by definitive surgery: Residual invasivedisease following neoadjuvant chemotherapy defined as: A contiguous focus ofresidual invasive cancer in the surgical breast specimen measuring ≥1 cm indiameter and/or with residual invasive cancer in at least one axillary node(micrometastases or macrometastases), as determined by local pathology review.- Definitive surgery followed by adjuvant chemotherapy: Pathological Prognostic Stage IIB, Stage IIIA, IIIB, or Stage IIIC disease according to the 8th edition of the American Joint Committee on Cancer (AJCC) Cancer Staging Manual.7. ...
Trial ID:
