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.

Breast Cancer

Breast Cancer Stage II

Breast Cancer Stage III

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

Paclitaxel

Only administered to patients with HER2-positive disease.

Perjeta

Herceptin SC

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

Tamoxifen

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).

Carboplatin

Lagos State University College of Medicine

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.

University of Chicago

Participants will receive standard care regarding nail toxicity. This entails advice to keep nails trim and the provision of a nail oil to massage into the nail daily. Participants will also receive advice in relation to general healthy living.

Participants will receive the same standard care as the control arm, except for the nail drops. The participants will also receive Onicolife nail drops to be applied twice daily.

Participants will receive the same standard care as the control arm, except for the nail drops. The participants will also receive a dark coloured nail polish to be applied as instructed.

Nail Toxicity

The prescription free, CE (Conformité Européenne) marked product is for local application, and has a novel mode of action involving the modulation of mast cell action with the fatty acid amide, Adelmidrol ®. Mast cells are known to have a key role in the ability of the body to promote healing /repair and control tissue damage caused by chemo and radiotherapy. This includes damage to the nail and/ or nail matrix. OnicoLife ® thus helps to control inflammation and pain whilst antimicrobial action also provides antibacterial and antifungal support.

Onicolife nail drops

One dark colour of nail polish (deep burgundy/red) will be used in this study since this colour is considered more acceptable to many more women than a pure black coloured nail polish and hence, more likely to ensure compliance. No nail polish containing hardeners will be used since there is some evidence to suggest they can induce nail changes. As dark nail polish can stain the nail plate (and therefore mask any changes in nail pigmentation induced by chemotherapy), one clear base coat, two coats of coloured, and one clear top coat of polish will be required for each application. This standard of application is proposed as a gold standard for the prevention of nail staining and hypersensitivity reactions by an eminent podiatrist (Spalding, 2008).

Nail polish

Beatson Oncology Centre

Taxane Chemotherapy and Nail Toxicity in Women With Breast Cancer; Stage Two: Evaluation of Interventions

Evaluate nail interventions (nail polish + standard care Vs Onicolife drops + standard care Vs Standard Care only) that may prevent or minimise the occurrence and severity of nail problems measured using the NToX-G12 (Nail Assessment Scale).

Evaluate nail interventions (nail polish + standard care Vs Onicolife drops + standard care Vs Standard Care only) that may prevent or minimise the occurrence and severity of nail problems measured using Common Terminology Criteria for Adverse Events v3.0 (CTC-AE v3).

Evaluate any change in the patient's quality of life, in relation to nail problems occurring, as measured using the NToX-QoL (quality of life questionnaire).

Evaluate any change in the patient's quality of life, in relation to nail problems occurring, as measured using the EQ-5D-5L (quality of life questionnaire)

Assess collected data for any correlating relationship between nail grade severity (measured using NToX-G12 - outcome measure 1) and qualify of life (measured using NToX-QoL - outcome measure 3).

taxol/atrophy

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

Taxane Chemotherapy and Nail Toxicity in Women With Breast Cancer; Stage Two: Evaluation of Interventions

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