Neoplasms

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Breast Neoplasms

Breast Diseases

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Bone Density Conservation Agents

Paclitaxel

Albumin-Bound Paclitaxel

Trastuzumab

Pertuzumab

Carboplatin

Fluorouracil

Tamoxifen

Hormones

Letrozole

Epirubicin

Prolactin Release-Inhibiting Factors

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Aromatase Inhibitors

Enzyme Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

Antineoplastic Agents, Hormonal

Selective Estrogen Receptor Modulators

Estrogen Receptor Modulators

Investigators plan to treat patients with paclitaxel weekly for a total of approximately 16 weeks (8 weeks before ultrasonography for response assessment and 8 weeks before surgery in good responders). Paclitaxel 80mg/m2 will be given on days 1, 8, 15 and so on for a total of 8 doses.

After first 8 weeks of paclitaxel, those with progressive disease (based on breast US assessment) or partial response but inoperable will have carboplatin added to their regimen. Patients will receive 8 cycles of weekly paclitaxel and carboplatin (PC).

Patients with poor response to 8 courses of paclitaxel followed by 8 courses of PC based on ultrasound assessment will be regarded as failing to respond to treatment. These patients will receive 4 cycles of 3-weekly FEC and will be followed up.

All Premenopausal patients will receive LHRH agonist for two years for contraception and fertility preservation.

Hormone-receptor positive patients will receive hormonal therapy with tamoxifen or letrozole after surgery, radiotherapy and LHRH agonist according to the expression of hormone receptors and according to the state of primary menopause at the onset of the study.

Patients with HER2-positive disease (see glossary and section 10.3) will receive 5 three-weekly courses of trastuzumab (Herceptin SC) with pertuzumab (Perjeta). After that pts will continue receiving trastuzumab to complete total of 18 doses within 1 year of treatment.

Administered to all patients for a minimum of 8 doses with a possible maximum of 16 doses.

Only administered to patients with HER2-positive disease.

Perjeta

Herceptin SC

Only administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole.

Administered to all premenopausal patients.

LHRH agonist

Only administered to patients who received paclitaxel and carboplatin, and were assessed as having poor response (defined as stable disease or progressive disease or partial response inoperable).

Only administered to patients who receive paclitaxel and were assessed as having poor response (defined as stable disease or progressive disease or partial response inoperable).

Olufunmilayo I. Olopade, MD

This is a two-stage phase II study with a single arm design. It will be conducted in women with breast cancer with stages IIA to IIIC (defined by AJCC 2009 classification) of all histological subtypes. All patients will receive 16 doses of paclitaxel; three breast ultrasound tests and tumor pathologic response evaluation will be used to assess the response to treatment.

Each patient will be assigned one of the following groups: 1) complete response, 2) partial response, 3) stable disease, 4) progressive disease, 5) early death from malignant disease, 6) early death from toxicity, 7) early death because of other cause, or 8) unknown (not assessable, insufficient data). Patients with a good response to 8 doses of paclitaxel (complete response or partial response that are operable) will receive an additional 8 courses of paclitaxel chemotherapy before surgery and radiotherapy. The overall response for these patients will be assessed by ultrasonography after a total of 16 weeks of Taxol therapy. Patients with poor response (defined as stable disease or progressive disease or partial response inoperable) as best response after eight weekly courses of paclitaxel will receive 8 cycles of weekly PC. The overall response for these patients will also be assessed by ultrasonography after 8 courses of PC therapy. Patients with poor response to 8 courses of paclitaxel followed by 8 courses of PC based on ultrasound assessment will be regarded as failing to respond to treatment. These patients will receive 4 cycles of 3-weekly FEC and will be followed up. Patients in response groups 4-8 above will be considered as failing to respond to treatment.

All conclusions will be based on all eligible patients. The schema for the study is presented in Figures 4-1, 4-2 and 4-3. Patients with a global deterioration of health status requiring discontinuation of treatment without objective evidence of disease progression at that time will be classified as having "symptomatic deterioration". Every effort will be made to document the objective progression even after discontinuation of treatment. All Premenopausal patients will receive LHRH agonist for two years for contraception and fertility preservation. Hormone-receptor positive patients will receive hormonal therapy with tamoxifen or letrozole after surgery, radiotherapy and LHRH agonist according to the expression of hormone receptors ER and PgR (see glossary and section 10.3) and according to the state of primary menopause (see glossary) at the onset of the study. Patients with HER2-positive disease (see glossary and section 10.3) will receive 5 threeweekly courses of trastuzumab (Herceptin SC) with pertuzumab (Perjeta). After that pts will continue receiving trastuzumab to complete total of 18 doses within 1 year of treatment.

The study is designed to estimate the RR of breast cancer patients to weekly paclitaxel chemotherapy and to determine the RR to weekly PC combination chemotherapy in patients resistant to or with poor response (including early progression) while on weekly single agent paclitaxel.

Assessing the Response Rate of Neo-adjuvant Paclitaxel (Taxol) in Nigerian Women With Breast Cancer

Assessing the REsponse Rate of Weekly Neo-adjuvanT pacliTAxel (Taxol) in Nigerian Women With Breast Cancer (ARETTA)

OCR will be calculated as the proportion of patients with an overall response of complete clinical response (CCR) or partial clinical response (PCR), where tumor response is based on change in tumor diameter after treatment.

The absence of residual invasive disease in the breast and in the axillary lymph nodes at the completion of treatment will be measured.

Incidence and severity of adverse drug reactions (AE) and serious adverse drug reactions (SAE) including clinical laboratory values, vital signs, ECGs and dose interruptions.

The various domains of QoL over time and the changes from baseline using the validated (by the European Organization for Research and Treatment of Cancer (EORTC)) QoL instrument (global and breast module).

Through correlative study of molecular markers and tumor subtypes/tumor biology with patient's characteristics, response to treatment and patients' outcome

To determine the profile of Perjeta given in combination with Herceptin SC, paclitaxel and paclitaxel + carboplatinum

To determine the profile of Herceptin SC given in combination with Perjeta, paclitaxel and PC

To determine the pattern of response to weekly paclitaxel and PC in combination with hormone therapy or with H/Ptz dual anti-HER2 blockade based on status of clinical markers ! Hormone receptors (ER and PgR) and HER2, and other markers.

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