I need a little bit of advice if anyone can suggest:
My mother who is 52 years old female, has recently been diagnosed for breast cancer.
She had been non diabetic, and a patient of hypothyroidism and (RA) rheumatoid arithritis. A brief history of hypothyroidism and Rheumatoid arithritis is as under:
Hypothyroidism: She has been suffering from hypothyroidism for about 12 years. Medicine taken: Thyronorm.
Rheumatoid Arithritis (RA): She has been suffering from Rheumatoid arithritis for about 18 years. Medicines taken: HCQS, SAAZ DS, Methotrexate, Arava, Medrol. A single dose of Rituximab injection was also taken in the year 2010.
She is post menopausal since 10 years. She has 2 children. Her first child was born at the age of 25 years. She breast fed them for 3 months. She has never used oral contraceptives/ hormone replacement therapy. Both her mother and father were diagnosed for cancer but in their old age. Her mother had stomach cancer and father had prostate cancer.
Breast Cancer: (T2 N0 M0)
She was diagnosed with Right Breast Carcinoma (IDC) and underwent Right BCS with oncoplasty (J-Mammoplasty) + Sentinel Lymph Node Biopsy on 03-september-2015 under GA.
Infiltrating Duct Carcinoma (NOS), Grade III (MBR score 8/9)- Right breast
Foci of tumor cell necrosis are seen.
Lymphatic/Vascular emboli- Absent.
Stromal Desmoplasia- Absent.
Axillary Lymphnodes: Total – 3 nodes ALL FREE (0/3).
Sentinel- 0/2 (Both Free) ; Non sentinel – 0/1 (Free).
pTNM Stage: p T2 N0 (sn) (Carcinoma – Right BCS sample) - [T2 N0 M0].
Estrogen receptor (ER) – Negative.
Progesterone receptor (PR) – Negative.
Her-2-neu (c-erb B2)= STRONGLY POSITIVE (Score 3+).
P53= Tumor cell p53 nuclear positivity – 35 to 40%.
Ki67= Tumor cell Ki67 proliferation index- 25 to 28 %.
Bone scan - negative.
After one week of surgery (BCS), she got infected with BILATERAL PYELONEPHRITIS along with SEPTICAEMIA (blood and urine culture positive for Ecoli, urine culture also positive for CRE (Klebsiella pneumonia) and remained hospitalized for about a month. Antibiotics administered during hospitalization were : Imipenem, Linezolid and Colistin. She is discharged and better now but still on oral antibiotics – Ferropenem and Nitrofurantoin. She is getting pus cells (about 10-15) in urine while still on antibiotics.
Now she has to undergo adjuvant chemotherapy along with radiation therapy.
There is a trial going ongoing for chemotherapy sponsored by Roche at MAX Parpargunj.
Details of trial:
Protocol Number: ML28714
Study Title: AN INDIAN MULTICENTRIC OPEN LABEL PROSPECTIVE PHASE IV STUDY TO EVALUATE SAFETY AND EFFICACY OF TRASTUZUMAB IN HER2 POSITIVE, NODE POSITIVE OR HIGH RISK NODE NEGATIVE BREAST CANCER AS A PART OF TREATMENT REGIMEN CONSISTING OF DOXORUBICIN, CYCLOPHOSPHAMIDE, WITH EITHER DOCETAXEL OR PACLITAXEL (AC -> TH) OR DOCETAXEL AND CARBOPLATIN (TCH).
My queries are:
1. Should my mother take the trial ? Is trial safer than normal chemotherapy?
2. If there would have been no trial, then do the prescribed medicines in the trial would still be the same as chemotherapy without trial ?
3. In the trial brochure given to patients, they have not mentioned anywhere about the dosage of medicines to be administered. So we are not aware of dosage of medicine to be given. So should we worry about the dosage of medicine in the trial?
4. Since there are so many chemotherapy regimes for breast cancer, which chemotherapy regimen would you have suggested (supposing there would have been no trial). Kindly also suggest the dosage of each medicine.
5. If you know, kindly tell us what kind of brand is ROCHE whose trial is going on?
Here I must include one more thing: Trial is free of cost to patients but that is NOT the reason we are considering to go for trial. My mother has enough health policies that she can easily go for normal chemotherapy (without trial). Money is NOT the consideration to go for trial.
We just want the right and safe chemotherapy treatment.
With enough hopes that you would help her take a better decision…. Thank you…..